MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 DELTA CER INSERT 28ID X 52OD; HIP ACETABULAR INSERT/LINER

Catalog Number 121883752

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/03/2014

Event Type  Injury  

Event Description

Hip revision surgery performed on (b)(6) 2014.The liner and the head were revised.Reason for revision: posterior ceramic liner fracture.Implants are not available for return.No x-rays available.

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 devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the lot code combinations at this current time.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.The complaint shall be closed with an undetermined conclusion; it will be entered into the complaint database and monitored through trend analysis.

• Brand Name: DELTA CER INSERT 28ID X 52OD
• Type of Device: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY (IRELAND) 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4363233
• MDR Text Key: 5265776
• Report Number: 1818910-2014-35160
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121883752
• Device Lot Number: 1094547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 12/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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