MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 48OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882748

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Joint Dislocation (2374)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Patient has been complaining of a "clunking" hip replacement after 2 years post-op.There has already been a revision change of head to the femoral stem to counteract the issue, but she still appears to be able to manually dislocate the hip with force.She has come back today for revision surgery again, this time to remove the cup and liner and replace with new components.Upon open the hip joint there were fragments of ceramic in the wound, this appeared to be from the ceramic liner as the head looks in pristine condition.Once cup was removed it appears there is a section of the ceramic liner that has fractured off, this is in line with the fragments found in the wound.The surgeon states that it is very hard to manually reproduce the dislocation the patient is experiencing.The head and liner both show signs of metal wear against components in keeping with the narrative of being able to dislocate at will.A new head, liner and cup were replaced.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received.States, that the affected side was the left hip.

Manufacturer Narrative

Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DELTA CER INSERT 32ID X 48OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18274619
• MDR Text Key: 329836721
• Report Number: 1818910-2023-24689
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121882748
• Device Lot Number: 9656514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DLT TS CER HD 12/14 32MM +9; PINN SECTOR W/GRIPTION 48MM
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female