MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Date 01/01/2000

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

"the literature article entitled, ""factors contributing to rapid wear and osteolysis in hips with modular acetabular bearings made of hylamer"" written by david l.Scott, md, dvm, phd, pat a.Campbell, phd, christian d.Mcclung, mphil, and thomas p.Schmalzried, md published by the journal of arthroplasty volume 15 no.1 2000 was reviewed.The article's purpose is to analyze radiographs, components and periarticular tissue retrieved at revision surgery to identify the factors associated with rapid wear and retro acetabular osteolysis with a modular acetabular liner made of hylamer.Data is compiled from 12 patients that are described in tables and narrative descriptions with associated adverse events.Each patient had depuy product implants and are individually captured in linked complaints.Osteolysis is attributed to poly liner wear.Also noted that article reports metal particles (debris) were found embedded in the liner which denotes head wear.Also noted that the article provides lot numbers for the poly liners." this complaint captures case 4 a (b)(6) male with r hip implants of aml femoral component and duraloc 100 acetabular component 60 mm, alo head 32 mm, 10 mm liner thickness from lot #786660 initially implanted (b)(6) 1992 and revised (b)(6) 1995 for poly wear and osteolysis.Femoral fixation was stable and acetabulum fixation was stable.Lysis found in femoral zone i and zones ii and iii of acetabulum.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9353912
• MDR Text Key: 185002344
• Report Number: 1818910-2019-115847
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR