MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR

Catalog Number UNK HIP FEMORAL SLEEVE ASR

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Article entitled, ¿the calpain gene is correlated with metal-on-metal hip replacement failures¿, by joseph j.Kavolus, md, mscr, alexander l.Lazarides, md, christina moore, ms, thorsten m.Seyler, md, phd, samuel s.Wellman, md, david e.Attarian, md, michael p.Bolognesi, md, benjamin a.Alman, md, published in j arthroplasty.2021 jan;36(1):236-241.E3.Doi: 10.1016/j.Arth.2020.07.054.Epub 2020 jul 30.Pmid: 32811707, was reviewed.The authors sought to determine whether certain immunologic genotypes are predictive of the need for revision in patients with metal-on-metal (mom) total hip implants.The study identified a genetic dna single-nucleotide polymorphism (snp), kgp9316441, encoding calpain proteins associated with inflammation and macrophage activation.This snp was associated with significantly increased odds of revision for mom hip revision.Of the 32 hips in the study, 15 were revised for mom disease, and 17 were not (the asymptomatic control group).Of the 15 revised, 7 were depuy asr hips, 6 were depuy pinnacle mom hips, and two were competitor products.Of the 15 revised, 5 presented with pseudotumors, 4 with alval (aseptic lymphocyte-dominant vasculitis associated lesion), and 15 with pain¿the study did not present these symptoms by product, but all were grouped together for the reported revisions.The specific treatments and products revised for each of these revision surgeries was not provided by the authors.The study also identified evidence of osteolysis radiographically for 2 revised patients, and for 2 unrevised patients¿no treatment was specified with regards to this finding.It was also noted that all patients, whether revised or presenting as asymptomatic, had elevations of there serum cobalt metal ions, from a low of 1.9 ug/l to 11 ug/l on the high end, and chromium metal ions from 1.8 ug/l to 13.5 ug/l¿and interestingly, the levels were nearly the same in both the revision and control groups.The study did not provide manufacturer data for femoral components (apart from the asr platform head and sleeve), nor did it break down the information by individual patient, such as through individual demographics¿age and gender.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: UNK HIP FEMORAL SLEEVE ASR
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12688907
• MDR Text Key: 283404912
• Report Number: 1818910-2021-23409
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL SLEEVE ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention