MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX CRV INS SZ5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-052
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Fever (1858); Unspecified Infection (1930); Pain (1994); Tachycardia (2095); No Code Available (3191)
Date of Event	02/13/2020
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
Clinical notification received for revision of left total knee to address infection date of implantation: (b)(6) 2019; date of revision: (b)(6) 2020; (left knee).Treatment: revision of tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative:  mfr#1818910-2020-07266 is being retracted since it was found to be a duplicate of mfr#1818910-2020-06413.Mfr# 1818910-2020-06413 will be kept for investigation purposes.
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
On (b)(6) 2020, the patient underwent a left knee revision due to pain, swelling, infection, fever, and effusion.Prior to revision, the patient had periods of tachycardia.The surgeon noted removal of fibrinous tissue.The tibial insert was the only product revised.All components were well fixed.The surgeon also performed an irrigation and debridement and placement of antibiotic pellets.

• Brand Name: SIG RP AOX CRV INS SZ5 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: 9808271
• Report Number: 1818910-2020-07266
• Device Sequence Number: 586341
• Product Code: NJL
• UDI-Device Identifier: 10603295076254
• UDI-Public: 10603295076254
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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: 1961-92-052
• Device Catalogue Number: 196192052
• Device Lot Number: 9036378
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 04/09/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/20/2020; 04/14/2020
• 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: DEPUY CMW 1 40G; MBT CEM KEEL TIB TRAY SZ5; MBT CEM KEEL TIB TRAY SZ5; PFC*SIGMA C/R NPOR FEM LT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 91