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 Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	08/31/2020
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 revision total knee replacement on (b)(6) 2014 ( hospital).At this stage a pfc tc3 rp system was utilized with a tabecular metal patella component from zimmer biomet.Patient has reported and ongoing niggle and has not been totally satisfied with the outcome.Patient has recently presented with a painful knee.The crp was reviewed and came back with an elevated reading indicating a knee infection.A decision was made to open the knee and perform a washout and bearing exchange on (b)(6) 2020.On opening the knee, there were no obvious signs of infection.Multiple soft tissue samples were taken, the knee debrided and washed out and new poly bearing implanted.It was noted that the knee was a little loose so the 10mm bearing that had been removed was replaced with a 15mm bearing.
Additional Manufacturer Narrative
Product complaint # (b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.
Additional Manufacturer Narrative
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 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: 10536532
• Report Number: 1818910-2020-20101
• Device Sequence Number: 2803641
• Product Code: NJL
• UDI-Device Identifier: 10603295242482
• UDI-Public: 10603295242482
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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,Followup
• Report Date (Section B): 08/31/2020

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: 488669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020; 11/10/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 09/15/2020; 11/11/2020
• 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 SZ 4; MBT TRAY SLEEVE POR M/L 45MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA TC3 FEM RT SZ5; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; UNIVERSAL FEM SLV DIS POR 34MM; UNIVERSAL STEM 115X12MM FLUTED; UNIVERSAL STEM 115X14MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR