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 Not Applicable (3189)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

(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 the ceramax ceramic acetabular liner cracked in multiple pieces after impacting into acetabular shell.Left side.

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 liner confirms the reported material fracture.The root cause is attributed to inadvertent use error.No manufacturing or material problem identified.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: product code 121887658, work order 9268477 was manufactured on 11-sep-2019.20 parts were manufactured per specification and all raw materials met specification.Device history review: product code 121887658, work order 9268477 was manufactured on 11-sep-2019.20 parts were manufactured per specification and all raw materials met specification.

• 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: 10251901
• MDR Text Key: 198319006
• Report Number: 1818910-2020-15408
• 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: 06/26/2020

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: 9268477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/13/2020; 01/25/2021
• Supplement Dates FDA Received: 07/14/2020; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 91