MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S4,10.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962351
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Der states that when removing 4/10mm tc3 rp poly, the surgeon observed unusual wear on the poly surface.Doi: unknown.Dor: (b)(6) 2018.Unknown knee.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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.Dhr reviewed; no nonconformances were noted.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S4,10.0
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7243731
• Report Number: 1818910-2018-52822
• Device Sequence Number: 917815
• Product Code: NJL
• UDI-Device Identifier: 10603295242345
• UDI-Public: 10603295242345
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 962351
• Device Lot Number: C54050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 01/18/2018; 01/18/2018; 03/07/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/06/2018; 02/13/2018; 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1