MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PFC SIGMA STAB+ INS 15MM SZ2.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2722
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient had fallen directly onto wound a few weeks after her revision on (b)(6) 2018.Surgeon did debridement and sutured back up however patient has presented with infection since.
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 will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 SIGMA STAB+ INS 15MM SZ2.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw MA 46582
• MDR Report Key: 7929612
• Report Number: 1818910-2018-71121
• Device Sequence Number: 2269434
• Product Code: JWH
• UDI-Device Identifier: 10603295243984
• UDI-Public: 10603295243984
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K963117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

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 Model Number: 96-2722
• Device Catalogue Number: 962722
• Device Lot Number: HJ8718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 03/06/2020
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/01/2018; 03/09/2020
• 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