MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,20.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2345
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2020
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
It was reported that the patient had a unstable knee and needed a conversion to a hinge knee.Doi: (b)(6) 2018, 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.Device history review: no deviations or nonconformances against this lot.

• Brand Name: TC3 RP TIBIAL INSERT S3,20.0
• 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: 10162639
• Report Number: 1818910-2020-13976
• Device Sequence Number: 11668358
• Product Code: NJL
• UDI-Device Identifier: 10603295242260
• UDI-Public: 10603295242260
• 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: 2018
• 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): 06/08/2020

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: 96-2345
• Device Catalogue Number: 962345
• Device Lot Number: 713682
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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: MBT REVISION CEM TIB TRAY S2.5; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; MBT TRAY SLEEVE POR M/L 45MM; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; PFC*SIGMA DIS AUG 8MM,SZ3,RGHT; PFC*SIGMA DIS AUG 8MM,SZ3,RGHT; PFC*SIGMA TC3 FEM RT SZ3; PFC*SIGMA TC3 FEM RT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; TC3 RP TIBIAL INSERT S3,20.0; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; PFC*SIGMA DIS AUG 4MM,SZ3,RGHT; PFC*SIGMA DIS AUG 8MM,SZ3,RGHT; PFC*SIGMA TC3 FEM RT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; TC3 RP TIBIAL INSERT S3,20.0; UNIVERSAL STEM 75X16MM FLUTED; UNIVERSAL STEM 75X18MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR