MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP ACETABULAR LINERS

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); No Code Available (3191)

Event Date 01/01/2004

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, "early osteolysis associated with trunion-liner impingement" written by mark earll, md, thomas fehring, md, william l.Griffin, md.J.Bohannon mason, md, and thomas h.Mccoy, md published by clinical orthopaedics number 418 january 2004 2004;418:153-156 was reviwed for mdr reportability.The article discuses 4 total case reports but only 3 are related to depuy products.The cases are captured on individual linked complaints.This complaint captures patient 1 (b)(6) yo man who received a depuy acetabular component with 10 degree hylamer liner and a prodigy femoral component in 1994.In 1999 he presented with radiographs revealing osteolysis with migration of the hole eliminator into the osteolytic cavity.The article reports: "at revision surgery, the acetabular component was ingrown with copious amounts of retroacetabular granulomatous debris.The elevated liner had a groove posteriorly where the trunion had impinged in extension and external rotation.The acetabular component was retained with exchange to a neutral +4 offset polyethylene liner.Morselized allograft was used to fill the retroacetabular cavitary lesion.Six months postoperative, the patient has resumed full activity and is pain-free." the article does not give any further information and does not provide acetabular implant angles.It is noted that wear on the poly liner is where the trunion of the stem was impinging upon the implant.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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 will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9106077
• MDR Text Key: 161987171
• Report Number: 1818910-2019-105536
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• 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: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention