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 Codes	Pain (1994); No Code Available (3191)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2016, the patient underwent total left knee arthroplasty due to arthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and competitor bone cement.On (b)(6) 2016, the patient underwent a left knee revision due to chronically dislocated patellar component secondary to malposition of femoral component and internal rotation.The surgeon reported femoral component had significant internal rotation.He noted the patellar component was in appropriated position, alignment, and was not loose.The surgeon indicated the tibial component was revised.The patient was implanted with depuy knee system.Competitor¿s cement was utilized, and there were no complications reported.On (b)(6) 2018, the patient underwent a left knee revision with poly exchange due to laxity, instability, and pain.The surgeon reported the femoral, tibial, and patellar components were well-fixed and retained.He indicated the poly was upsized for improved extension and flexion.There were no complications reported.Two depuy cement products were used during primary operation.Please add hospital account information.Awareness date is 03 december 2019.
Additional Manufacturer Narrative
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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9497379
• Report Number: 1818910-2019-124134
• Device Sequence Number: 2981181
• Product Code: NJL
• UDI-Device Identifier: 10603295242260
• UDI-Public: 10603295242260
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: 657824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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: ATTUNE MEDIAL ANAT PAT 35MM; COMPETITOR'S BONE CEMENT; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ3 8MM; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA DIS AUG 4MM,SZ3,LEFT; PFC*SIGMA TC3 FEM LEFT SZ3; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR