MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG RP AOX STB INS SZ2.5 17.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1961-92-124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	11/24/2019
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 adverse event received for left knee deep infection--staphylococcus aureus, knee washout with poly swap.Event is serious and is considered moderate.Event is definitely related to device and there is a remote possibility it is related procedure.Date of implantation: (b)(6) 2019; date of event (onset): (b)(6) 2019; (left knee).
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.

• Brand Name: SIG RP AOX STB INS SZ2.5 17.5
• 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: 9676811
• Report Number: 1818910-2020-04141
• Device Sequence Number: 11396891
• Product Code: NJL
• UDI-Device Identifier: 10603295076476
• UDI-Public: 10603295076476
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2020

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: 1961-92-124
• Device Catalogue Number: 196192124
• Device Lot Number: 8288043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/21/2020
• 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 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY S2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG TIB CEM STM 13X60 2/2.5/3; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ2.5 L; TAPER CEM STEM 13X90; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; DEPUY CMW 3 40G; MBT REVISION CEM TIB TRAY S2.5; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG TIB CEM STM 13X60 2/2.5/3; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA PS CEM FEM SZ2.5 L; TAPER CEM STEM 13X90
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 50