MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CERAMAX CERAMIC INSERT 36 X 58; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Model Number 1218-87-658

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

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

It was reported that on (b)(6) 2020, they had used a 36/58 ceramic liner to implant into the patient.As the surgeon was impacting the ceramic liner into the patient, the liner edge chipped off.He proceeded to remove all pieces of the ceramic that had chipped off.After the chipped pieces were out of the patient he then took the liner out, and did a deep washout to ensure no other pieces were in the patient.We then used a regular altrex liner for the patient instead of the ceramic liner.All chipped parts of the liner were explanted out of the patient, and thrown away.The main part of the liner was washed and sent back to our office.The surgeon did confirm that there was no ceramic debris left in the patient.Doe: (b)(6) 2020.Affected side: unknown.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device confirms the reported material fracture.Misalignment during impaction leads to a point contact between the insert and shell, contributing to material chipping and/or fracture.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, 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: protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the insert conformed to the specification valid at the time of production.

• Brand Name: CERAMAX CERAMIC INSERT 36 X 58
• 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: 10749751
• MDR Text Key: 213649779
• Report Number: 1818910-2020-23471
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295012542
• UDI-Public: 10603295012542
• Combination Product (y/n): N
• PMA/PMN Number: K000306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-658
• Device Catalogue Number: 121887658
• Device Lot Number: 9413749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/24/2020; 12/11/2020
• Supplement Dates FDA Received: 10/30/2020; 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1