MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 11/22/2018

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, "capsular closure outweighs head size in preventing dislocation following revision total hip arthroplasty" written by christopher pedneault, dylan tanzer, anas nooh, karen smith and michael tanser published by hip international accepted by publisher on 22 november 2018 was reviewed.The purpose of the article was to compare the dislocation rates in revision cases that received either 28 mm, 32 mm or large 36 mm femoral head components.Data was compiled from 48 hips, 47 hips and 49 hips respectively.Article reports 3 of the 144 hips dislocated.It is noted that 2 of the 3 hips were identified with depuy products and captured in this complaint as follows: first case is 32 mm head group a (b)(6) years old male who underwent acetabular liner exchange for excessive poly wear and pelvic osteolysis.The acetabular component 56 mm duraloc cup and srom stem were well fixed and left in place.A 10 degree oblique poly liner oriented superiorly was inserted to compensate for the 57 degree abduction angle of the cup.The 28 mm head was replaced with a 32 mm +3 co cr head.The patient then experienced a posterior dislocation 11 months postop and treated with non-operative posterior hip precautions for 3 months and suffered no further dislocations at 2 years follow up.Depuy product and adverse event: poly liner - revised for wear and osteolysis; duraloc cup - mispositioned but left in situ; femoral head and poly liner - dislocation treated non-operatively.Third case is (b)(6) years old male with failed metal-metal-metal asr xl tha presenting with pain, severe acetabular osteolysis, elevated metal ions but no pseudotumor.Intraoperatively, depuy trilock stem was well fixed and left in situ, and the acetabular and femoral components were replaced with non-depuy components which was followed by a dislocation.He was treated non-operatively with posterior hip precautions and suffered no further dislocations.Depuy product and adverse event: asr xl cup, asr xl head, revised for pain, acetabular osteolysis, elevated metal ions (attributed to bearing wear).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10306313
• MDR Text Key: 200795157
• Report Number: 1818910-2020-16486
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• 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: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention