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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 10/13/2020

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.

Event Description

Per surgeon, pt has mal rotated cup and poly wear.No records other than case done in 1997 in mason city.Not sure exact month or day.No records available.Surgeon removed head, duraloc 54 cup and liner.Pt has prodigy stem in that is staying.Surgeon put in competitive mdm cup.Doi: (b)(6) 1997 - dor: (b)(6) 2020 (left hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Although not returned poly material wear after more than 20 years implanted is not unreasonable to have identified.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 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: 10749514
• MDR Text Key: 213494603
• Report Number: 1818910-2020-23464
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE BALL 28 +5 BR.; CUST DURALOC 56MM SHELL.; UNK HIP LOCKING RING.; ARTICUL/EZE BALL 28 +5 BR; CUST DURALOC 56MM SHELL; UNK HIP LOCKING RING
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 84