MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP CV TB/IN S4 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	962042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Osteolysis (2377); No Code Available (3191)
Date of Event	08/06/2018
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.(b)(4).
Event or Problem Description
Revision due to osteolysis and pain.Doi: (b)(6) 2014; dor: (b)(6) 2018; right knee.
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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: PFC SIGMARP CV TB/IN S4 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7995466
• Report Number: 1818910-2018-73243
• Device Sequence Number: 1255884
• Product Code: NJL
• UDI-Device Identifier: 10603295240822
• UDI-Public: 10603295240822
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 09/06/2018

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: 962042
• Device Lot Number: 7894180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: 58 YR
• Patient Weight: 91