MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS TITANIUM 60MM CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Distress (2329); Deformity/ Disfigurement (2360)

Event Date 09/20/2022

Event Type  Injury  

Event Description

Asr litigation record received.Litigation alleges severe hip pain, discomfort, elevated metal ions, emotional distress, disability, disfigurement, permanent physical and economical injuries.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference report #mw5119377.

Event Description

Additional information received on 7/28/2023 for report mw5119376 to change mfr.

• Brand Name: TITANIUM 60MM CUP
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): DEPUY ORTHOPAEDICS
• MDR Report Key: 17324515
• MDR Text Key: 319119366
• Report Number: MW5119376
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1