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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

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

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The literature article entitled, 'otto aufranc award: crosslinking reduces tha wear, osteolysis, and revision rates at 15-year follow-up compared with noncrosslinked polyethylene', written by robert h.Hopper, jr.Phd, henry ho ms, supatra sritulanondha, mph, ann c.Williams bs, and charles a.Engh, jr.Md published by clinical orthopaedics and related research published online 17 january 2018 was reviewed.The purpose of the article is to compare xlpe (highly crosslinked polyethylene liners) and cpe (conventional polyethylene) to compare results for lower rate of revision for wear-related complications, a reduced wear rate, and lower frequency of osteolysis.All implants were depuy and the liners compared were marathon (xlpe) and eduron (cpe).Duraloc cups were utilized without screws.Stems were either aml, solution, or prodigy.All femoral heads were cocr material.Data was compiled from 220 patients (230 hips) implanted beginning in january 1999 without provided end date.The article reports all cups and stems were well fixed.Depuy products: marathon liner (xlpe), enduron liner (cpe), duraloc cup, aml stem, solution stem and prodigy stem.Adverse events: the article provides radiographic image (figure 3) of 43 year old man who had no evidence of osteolysis at 8 year follow up but had note of proximal femoral osteolysis at 16 year follow up.No revision was performed but figure description notes liner wear rate.Cross reference with narrative description and reference to figure 3 reveals liner is marathon.Identified patient of 85 year old female not revised but noted to experience greater trochanter fracture without osteolysis.Narrative description provides identity of liner as enduron liner.Trochanter fractures post op attributed to osteolysis associated with liner wear (treated by revision of liner): both liners.Osteolysis associated with identified liner wear (treated by revision): both liners.Osteolysis associated with identified liner wear (not revised or treated): both liners.

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.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.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: 9835460
• MDR Text Key: 215143067
• Report Number: 1818910-2020-08014
• 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: 03/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1