MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PFC SIGMARP STB TB IN 5 15.0; KNEE TIBIAL BEARING/INSERT

Catalog Number 962153

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 05/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

Patient was revised to address pain, implant fracture and tibial loosening at the bone/cement interface.The cement manufacturer is unknown.

Manufacturer Narrative

The device associated with this report were not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Patient x-rays were provided.No other additional information was obtained.Review of the supplied patient x-rays dated (b)(6) 2014 did not find evidence of implant fracture, disassociation, or anything indicative of a device nonconformance.It is unknown if the reported device fractured after (b)(6) 2014 (date of x-rays).The revision surgery was reported as (b)(6) 2016.A complaint database search finds no additional reports against the provided product and lot combination.A device history records review was not conducted for the reported fractured tibial insert as provided information stated the femoral adapter bolt fracture was the cause of the insert to fracture.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to determine a root cause or find evidence indicating product error was a contributing factor, a need for corrective action is 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 5 15.0
• 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: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5709364
• MDR Text Key: 46901379
• Report Number: 1818910-2016-20924
• Device Sequence Number: 1
• Product Code: NJL
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 962153
• Device Lot Number: 7782286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2013
• 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 Age: 65 YR