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 Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 09/16/2020

Event Type  Injury  

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

Patient underwent right primary total hip replacement approximately 20 years ago in (b)(6); surgeon, date and hospital unknown.Patient has presented with a painful right hip.X rays indicate polyethylene wear of the s rom cup (eccentric wear noted on the x ray) along with osteolysis around both the cup and the proximal stem.A decision was made to revise the cup, and leave the stem in situ ((b)(6) 2020, (b)(6)).The cup was removed, and it was noted that the polyethylene liner had worn through and the ceramic head was articulating on the metal shell, both the metal shell, and the ceramic head were damaged.The s rom acetabular component was removed, and replaced and a new s rom 36mm head implanted on the s rom stem, which was left in situ.(the removed head was a 28mm +6 biolox ceramic head).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided images confirmed the reported allegation.The root cause could not be determined.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.Device history lot : the lot number was not provided.

• 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: 10601107
• MDR Text Key: 215975453
• Report Number: 1818910-2020-21123
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 28MM +6 BIOLOX CERAMIC HEAD; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR