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

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 05/18/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Patient code: no code available ((b)(4)) used to capture surgical intervention.Additional narrative: 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

"literature article entitled, ¿highly cross-linked polyethylene decreases the rate of revision of total hip arthroplasty compared with conventional polyethylene at 13 years¿ follow-up¿ by s.A.Hanna, et al, published by the bone and joint journal (2016), vol 98-b, pp.28-32, was reviewed.The purpose of this study was to compare the long-term results of primary total hip arthroplasty (tha) in young patients using either a conventional (cpe) or a highly crosslinked (hxlpe) polyethylene liner in terms of functional outcome, incidence of osteolysis, radiological wear and rate of revision.Implanted depuy products: 58 duraloc cups, 37 enduron liners (cpe group), 21 marathon liners (hxlpe group), 7 s-rom stems, and 44 prodigy stems.This study also included heads, cups, liners, and stems from competitor manufacturers that are not included within this complaint.Results: 5 enduron cpe liners revised for osteolysis and polyethylene wear; 2 head and liner revisions of the marathon hxlpe liner for joint instability; 1 revision of a femoral stem and s-rom sleeve (augment) (product not specified within the text of the article) for femoral loosening.15 radiologically identified acetabular osteolysis associated with the enduron liner; 16 radiologically identified femoral osteolysis associated with the enduron liner; there was no osteolysis or polyethylene wear found associated with the marathon liner.There were no adverse events or revisions associated with the duraloc acetabular cup.

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.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: 9243151
• MDR Text Key: 172625334
• Report Number: 1818910-2019-109006
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention