MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S3,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2343
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373); No Code Available (3191)
Date of Event	06/24/2020
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
Patient underwent primary unicompartmental surgery.This was revised to a pfc tc3 revision on (b)(6) 2014 (please note that i do not believe that the uni knee was a depuy product but a complaint search may establish this).Following the pfc tc3 revision, the patient has complained that the knee has never felt good.Recent x rays show extensive heterotopic ossification, especially around the lateral edges of the tibial component.A decision was made to open the knee on (b)(6) 2020 to remove the extra bone.As expected there was fairly extensive bone around the lateral edges on the component which appeared to be impinging on both the soft tissue and the mobile bearing insert.This bone was removed and a new 15mm tc3 rp bearing inserted (same bearing that was removed to gain exposure.
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.H6 patient code: no code available (3191) used to capture the device revision or replacement and not surgical intervention.

• Brand Name: TC3 RP TIBIAL INSERT S3,15.0
• 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: 10285501
• Report Number: 1818910-2020-16083
• Device Sequence Number: 19005100
• Product Code: NJL
• UDI-Device Identifier: 10603295242239
• UDI-Public: 10603295242239
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 06/23/2020

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: 96-2343
• Device Catalogue Number: 962343
• Device Lot Number: 447698
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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: PFC*SIGMA TC3 FEM RT SZ3; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIGMA FEM ADAPTER 5 DEGREE; SIGMA FEM ADAPTER NEUTRAL BOLT; TC3 RP TIBIAL INSERT S3,15.0; UNIVERSAL STEM 75X10MM FLUTED; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR