MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ2 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); No Code Available (3191)
Date of Event	06/09/2020
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
The patient was revised due to a tight knee.It was reported that the surgeon had cut the patella wrong.Doi: (b)(6) 2019, dor: (b)(6) 2020, right knee.
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.H10 additional narrative: added: h6 (patient).

• Brand Name: SIG RP AOX CRV INS SZ2 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10191883
• Report Number: 1818910-2020-14394
• Device Sequence Number: 14207577
• Product Code: NJL
• UDI-Device Identifier: 10603295076094
• UDI-Public: 10603295076094
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 1961-92-012
• Device Catalogue Number: 196192012
• Device Lot Number: 8250489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG RP AOX CRV INS SZ2 12.5; PFC*SIGMA/RD/DOME PAT 3PEG,32; SIG RP AOX CRV INS SZ2 12.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR