MAUDE Adverse Event Report: DEPUY IRELAND ¿ 9616671 PFC SIGMARP CV TB/IN S2 12.5; KNEE TIBIAL BEARING/INSERT

Catalog Number	962012
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Swelling (2356); No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that there was a failure of the insert, due to "clunk" noise coming from the knee.Update 5-1-2017: medical records have been reviewed.Primary operative note (b)(6) 2010 indicates the patient received a right pfc total knee replacement.No complications noted by the surgeon.Clinical notes (b)(6) 2017 indicate the patient was being seen for instability, pain, swelling and clunking of the right total knee replacement.It can be gathered that the reported "clunk" is more of a sensation than a noise.Revision operative notes (b)(6) 2017 indicate during the surgery the surgeon noted severe posterior polyethylene wear, no evidence of infection, components were well fixed.There was also natural patella baja with chondral damage.The revision was completed without any complication noted by the surgeon.Reportability has been updated.Updated 8-16-2017.
Additional Manufacturer Narrative
The device associated with this report was not returned for evaluation.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC SIGMARP CV TB/IN S2 12.5
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY IRELAND ¿ 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 6797660
• Report Number: 1818910-2017-22870
• Device Sequence Number: 149612
• Product Code: NJL
• UDI-Device Identifier: 10603295240587
• UDI-Public: 10603295240587
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 962012
• Device Lot Number: 2820033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 45