MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S2.5,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2333
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/09/2020
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
This pc related to (b)(4).The primary surgery was performed on an unknown date via tka for the patient¿s right knee joint.The 1st revision surgery was performed on (b)(6) 2015 (this event was reported as (b)(4).).The 2nd revision surgery was performed on (b)(6) 2020 by replacing the tibial tray, the tibial sleeve, the tibial stem and the tibial insert (this event was reported (b)(4)).When the 2nd revision surgery, the surgeon inserted the tibial insert (p/n: 962333, size2.5/15mm) and the tibial tray (mbt/rev#1.5, p/n: unknown, size1.5), and there was size¿s mismatch between the tibial side implants and a femoral component (size2.5, p/n: unknown).The surgeon accepted this mismatch.It was reported that the 3rd revision surgery was performed on (b)(6) 2020 by replacing the tibial insert and repairing patella tendon due to rupture of patella tendon.The surgeon thought that the tibial insert was oversize for the tibial tray, and this might cause the rupture of patella tendon.Therefore, the surgeon inserted a tibial insert (size1.5/ 17.5mm thick, p/n: unknown) this time.The surgeon accepted size¿s mismatch between femoral component and the tibial insert.The surgery was completed, and it was unknown whether there was any surgical delay.No further information is available.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: TC3 RP TIBIAL INSERT S2.5,15.0
• 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: 10178609
• Report Number: 1818910-2020-14234
• Device Sequence Number: 2400351
• Product Code: NJL
• UDI-Device Identifier: 10603295242147
• UDI-Public: 10603295242147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-2333
• Device Catalogue Number: 962333
• Device Lot Number: HF2241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/20/2020
• 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: UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention