MAUDE Adverse Event Report: DEPUY (IRELAND) 9616671 PFC SIGMARP STB TB IN 4 12.5; KNEE TIBIAL BEARING/INSERT

Catalog Number 962142

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Patient was revised due to spin-out with the ploy and undersized ploy thickness.

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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.No additional information was obtained.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not 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: PFC SIGMARP STB TB IN 4 12.5
• Type of Device: KNEE TIBIAL BEARING/INSERT
• 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: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3724468
• MDR Text Key: 4326984
• Report Number: 1818910-2014-15860
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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: 962142
• Device Lot Number: 7796302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 04/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2013
• 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 Weight: 86