MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 01/01/2011

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"the literature article entitled, ""contemporary total hip arthroplasty with and without cement in patients with osteonecrosis of the femoral head"" written by young-hoo kim, md, jun-shik kim, md, jang-won park, md, and jong-hwan joo, md published by the journal of bone and joint surgery 2011 was reviewed.The article's purpose was to analyze the long-term results associated with contemporary cemented and cemntless total hip replacements with an emphasis on the rates of osteolysis and revision, in patients with osteonecrosis of the femoral head who were followed for a minimum for 16 years.The data was compiled from 46 patients with unilateral fully cementless arthroplasty and 48 patients with bilateral arthroplasty (94 patients 142 hips).Depuy products utilized in bilateral arthroplasties (hybrid group): cementless acetabular duraloc cups in all hips; elite or elite plus cemented stem in one hip and profile cementless stem in the contralateral hip.Depuy products utilized in unilateral arthroplasties (fully cementless group): cementless acetabular duraloc cups in all hips; profile cementless stem.Poly liners in all cups.Adverse events: acetabular osteolysis, femoral osteolysis adjacent to component, revision for infection (hybrid group and both components revised), revision for periprosthetic fracture of stem (fully cementless group ), revision of well fixed acetabular shells because of liner wear and osteolysis (both groups).The article states ""no hip in either group had aseptic loosening of the acetabular metal shell or femoral stem."" the article does not report of any debris but associates liner wear with osteolysis.The article does not provide adequate information to determine accurate quantities." this complaint captures the radiographic image with patient in the hybrid group identifier of a (b)(6) male with femoral heads showing eccentric migration of 3 mm vertically "suggesting wear of polyethylene liner." acetbular osteolysis is noted in zones i and ii in both hips and no femoral osteolysis.The article does not provide any further information regarding intervention for findings but associates osteolysis with liner wear.

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.H10 additional narrative: corrected: h6 product complaint # (b)(4).Investigation summary
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> 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 code(s) was not provided.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.Corrective action was not indicated.Device history lot
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> null device history batch
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> null device history review
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> null if information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9264788
• MDR Text Key: 188471508
• Report Number: 1818910-2019-113534
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR