MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 SELF CENT HIP 41X28 RUST; HIP OTHER IMPLANT

Catalog Number 103541000

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem No Information (3190)

Event Date 04/06/2015

Event Type  Injury  

Event Description

Patient was revised to address a broken bipolar liner, which caused the bipolar head to disassociate.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

Examination of the reported device was not possible as it was not returned.A search of the complaints databases finds no other reports against the product and lot code combination since its release to distribution.An x-ray was provided for examination confirming the reported implant disassociation.The femur is secured with a trauma plate and several control cables, one of which is broken, and the bipolar head has rotated into a vertical position.No medical records or additional event information was provided to customer quality.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 41X28 RUST
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4690381
• MDR Text Key: 5711900
• Report Number: 1818910-2015-18465
• 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: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2005
• Device Catalogue Number: 103541000
• Device Lot Number: U6BAW1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2000
• 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: 54 YR