MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,10.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2361
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/15/2020
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 to address infection and all implants were removed.The patient has multiple health issues including cancer.The patient began to have an issue with the knee approximately 3 months ago and by the time he came in, he was grossly infected with a draining sinus.A static spacer was placed after thorough i&d.Doi: (b)(6) 2013, dor: (b)(6) 2020, left 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: TC3 RP TIBIAL INSERT S5,10.0
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11117752
• Report Number: 1818910-2021-00254
• Device Sequence Number: 3923296
• Product Code: NJL
• UDI-Device Identifier: 10603295242482
• UDI-Public: 10603295242482
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 12/16/2020

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: 96-2361
• Device Catalogue Number: 962361
• Device Lot Number: 266355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/29/2021
• 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: MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 29MM; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S5,10.0; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 29MM; PFC*SIGMA TC3 FEM LEFT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S5,10.0; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR