MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number 96-2362

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/14/2020

Event Type  Injury  

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 Description

Patient underwent primary tkr where a stryker knee was utilized.This knee was later revised to a stryker revision.On the (b)(6) 2015 the stryker revision knee was revised to a pfc tc3.Patient has presented with a painful and stiff knee, with a limited range of motion.Bone scans show an uptake around the femoral component indicating a possible loose femoral component.A decision was made to revise the femoral component and bearing on (b)(6) 2020.On opening the knee, the femoral component was not overtly loose and did require a little work to remove.It was, however considered to be loose.A decision was made to convert the tc3 femur to an s rom hinged knee (allowing more mobility) while leaving the revision tibial tray in situ.

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 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.Device history lot no deviations or non-conformances were noted.

• Brand Name: TC3 RP TIBIAL INSERT S5,12.5
• Type of Device: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10581860
• MDR Text Key: 208395775
• Report Number: 1818910-2020-20865
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295242499
• UDI-Public: 10603295242499
• Combination Product (y/n): N
• PMA/PMN Number: K802627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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
• Device Operator: Health Professional
• Device Model Number: 96-2362
• Device Catalogue Number: 962362
• Device Lot Number: 498997
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY SZ 4; PALACOS CEMENT; 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 STEM 115X14MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED; MBT REVISION CEM TIB TRAY SZ 4; PALACOS CEMENT; 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 STEM 115X14MM FLUTED; UNIVERSAL STEM 115X16MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR