MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD CERAMIC; CERAMIC FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD CERAMIC

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Osteolysis (2377)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 patient was revised due to hip pain and upon x-ray determined lysis of acetabulum.The patient has, lot #s are unreadable.Nothing further to add.Doi: (b)(6) 2009.Dor: (b)(6) 2020; right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.H10 additional narrative: added: b5 corrected: h6 (device code).

• Brand Name: UNK HIP FEMORAL HEAD CERAMIC
• Type of Device: CERAMIC FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11088969
• MDR Text Key: 224148006
• Report Number: 1818910-2020-27780
• 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: 12/14/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD CERAMIC
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER METAL; UNK HIP ACETABULAR LINER METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 106