MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 36 X 54; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Model Number 1218-87-654

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 12/02/2020

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

This is a revision of the corail and pinnacle hip.This was revised due to the corail stem's subsidence, and the ceramic lined was chipping off.

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 indicated that the patient was experiencing pain that led to the revision surgery.Affected side if left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Photographs of the explanted device appears to depict some material chipping on the face of the liner.It is not possible to determine a root cause using photographic images.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: a device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 54
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11021022
• MDR Text Key: 221820039
• Report Number: 1818910-2020-27090
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295012528
• UDI-Public: 10603295012528
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-654
• Device Catalogue Number: 121887654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL2 NON COL HO SIZE 11.; DELTA CER HEAD 12/14 36MM +5.; PINNACLE 100 ACET CUP 54MM.; CORAIL2 NON COL HO SIZE 11; DELTA CER HEAD 12/14 36MM +5; PINNACLE 100 ACET CUP 54MM
• Patient Outcome(s): Required Intervention