Evidence map›Paper›PMID 33407687›Full record

ArticlePatient safety in surgery2021

Living with a recalled implant: a qualitative study of patients' experiences with ASR hip resurfacing arthroplasty.

Christian Bitar, Ferid Krupic, Li Felländer-Tsai, Sead Crnalic, Per Wretenberg

Open access · goldAbstract read
In one paragraph

Article in Patient safety in surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Ethical Considerations in Disclosing Orthopedic Implant Failures to Patients.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2026
    Article
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Christian BitarDepartment of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden. christian.bitar@ki.se.ORCID http://orcid.org/0000-0003-4253-2024
Ferid KrupicDepartment of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Li Felländer-TsaiDivision of Orthopedics and Biothechnology, Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Sead CrnalicDepartment of Surgical and Perioperative Sciences (Orthopaedics), Umeå University, Umeå, Sweden.
Per WretenbergDepartment of Orthopaedics, School of Medical Sciences, Örebro University and Örebro University Hospital, Örebro, Sweden.
Karolinska University Hospital · SEÖrebro University · SEUmeå University · SEUniversity of Gothenburg · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTotal hip arthroplasty is the traditional treatment for osteoarthritis in the hip joint. Hip resurfacing arthroplasty, with metal on metal bearing, is a modern concept initially developed mainly for young active people. The metal-on-metal hip arthroplasty implant, Articular Surface Replacement (ASR), was implanted in approximately 93,000 patients before it was recalled in 2010 due to a high complication rate. This study aimed to evaluate patients' own experiences living with an implant that they knew had a high complication rate and had been recalled from the market.

methodsA total of 14 patients, still living with the implant, of a cohort of 34 patients were available for follow-up. Qualitative semi-structured interviews were conducted with 14 patients where a majority actively sought for metal-on-metal hip resurfacing arthroplasty (HRA), and subsequently underwent HRA with an ASR prosthesis between 11/21/2006 and 09/28/2009. The responses were analyzed using content analysis described by Graneheim and Lundman to compress text and identify categories and subcategories.

resultsThe results showed that most patients had already decided that they wanted a metal-on-metal HRA implant before meeting the surgeon. They expressed that the implant made it possible to live an active life. A majority did not think about the fact that they had a hip implant, because they lacked subjective pain. Most of the patients were positive about the annual exams at the hospital and wanted them to continue. None of them felt that their trust towards the healthcare system had changed after the implant recall. They expressed a belief that they would need new surgery sooner than they first thought.

conclusionsDespite all the attention when the ASR prosthesis was recalled, patients with ASR-HRA did not report themselves negatively affected by the recall in this group of patients where a majority had actively sought for an HRA procedure. The healthcare system has an obligation to continue the annual exams, even if the implant provider does not continue reimbursement.

Indexed as

Articular surface replacementHealthcare providersHip resurfacing arthroplastyInterviewsMedical device recallProsthesis failureQualitative researchTotal hip replacement

Identifiers

PMID33407687
PMCPMC7788783
OpenAlexW3118431673

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.