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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pain (1994); Injury (2348); Joint Dislocation (2374); Osteolysis (2377)

Event Date 01/01/2012

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.(b)(4).

Event Description

The literature article entitled, "cementless total hip arthroplasty in patients fifty years of age or younger: a minimum ten-year follow-up" written by ryan k.Takenaga, ma, md, john j.Callaghan, md, nicholas a.Bedard, bs, steve s.Liu, md, alison l.Klaasen, ma and douglas r.Pedersen, phd published by the journal of bone and joint surgery, incorporated 2012 was reviewed.The article's purpose was to evaluate the results of cementless total hip arthroplasty performed in a consecutive series of patients fifty years of age or younger who were followed for a minimum of ten years.Data was compiled from 73 patients (82 hips).All stem components were depuy products but acetabular components were either depuy or non depuy.The article does not provide adequate information to determine accurate quantities and does not specify which products are related to the adverse events.Depuy products utilized: prodigy stems, duraloc cups with poly liners, metal femoral head.Adverse events: poly wear (treated with revision - head and liner exchange), periprosthetic femoral fracture (treated with revision - femoral component explanted and not explanted with plating), dislocation (treated with revision - head and liner exchange), thigh pain (no interventions; radiographic findings of stress shielding (no interventions), osteolysis (associated with poly wear), radiolucency's (no revisions for loosening or migration).

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: 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.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: 9412377
• MDR Text Key: 184822125
• Report Number: 1818910-2019-120298
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• 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 Outcome(s): Required Intervention