MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S5,17.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962364
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Not Applicable (3189)
Date of Event	08/09/2018
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
The patient was revised to address infection.All implants were stable.No implants were broken during surgery so none were needed to be retrieved.Doi: unknown; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: TC3 RP TIBIAL INSERT S5,17.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0998
• MDR Report Key: 7845684
• Report Number: 1818910-2018-68431
• Device Sequence Number: 2062264
• Product Code: JDI
• UDI-Device Identifier: 10603295242536
• UDI-Public: 10603295242536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K802627
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 962364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 09/26/2018
• 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: 56 YR