MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SELF CENT HIP 42X28 RUST; HIP OTHER IMPLANT

Catalog Number 103542000

Device Problems Disassembly (1168); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

The type of this complaint is revision due to a breakage and disassociation of implant.Visual observation discovered wear not breakage.

Manufacturer Narrative

Examination of the returned device confirms the report.The collar was reviewed by the quality inspector and it was found to be damaged, therefore could not be measured.The metal bearing and the poly shell were measured and were both dimensionally within print tolerance.No additional investigational inputs were made available for review.A search of the complaints databases finds no other reports against the product and lot code combination since its release to distribution.Review of device history records finds no related manufacturing deviations or anomalies that would have contributed to the reported event.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SELF CENT HIP 42X28 RUST
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 5090488
• MDR Text Key: 26264483
• Report Number: 1818910-2015-31036
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2003
• Device Catalogue Number: 103542000
• Device Lot Number: SR1BC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/1998
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR