MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ4 15; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-043
Date of Event	12/05/2020
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
Clinical notification received for revision of left total knee to address septic knee.Date of implantation: (b)(6) 2020, date of revision: (b)(6) 2020, (left knee).Treatment: surgical i&d, tibial insert revised.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
On (b)(6) 2020, the patient underwent a primary left total knee arthroplasty.The surgeon indicated retained tibial hardware from previous knee surgeries.The manufacturer of the hardware is unknown.On (b)(6) 2020, the patient underwent a left knee revision with tibial insert exchange, irrigation and debridement, and placement of antibiotic pellet to address infection.Prior to revision, the patient was also experiencing pain, discomfort, swelling, fever, effusion, and instability.The surgeon noted the patient would be on iv antibiotics for 6 weeks following revision.On (b)(6) 2020, the patient presented for a post-operative evaluation with some eschar around wound, mild effusion, and some swelling in the leg down to the foot.

• Brand Name: SIG RP AOX CRV INS SZ4 15
• 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: 11124627
• Report Number: 1818910-2021-00470
• Device Sequence Number: 14438318
• Product Code: NJL
• UDI-Device Identifier: 10603295076223
• UDI-Public: 10603295076223
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

1 Device 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: 1961-92-043
• Device Catalogue Number: 196192043
• Device Lot Number: 9224998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 02/05/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/29/2021; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No