MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TC3 RP TIBIAL INSERT S5,15.0; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Model Number	96-2363
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	06/11/2020
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 revision surgery was for instability.At this time dr.Removed all primary components and implanted a pfc tc3 rp revision system.Patient has now presented with pain around the knee and the feeling of instability (and sometime feels the knee is hyperextending.A decision was made to open the knee and confirm a diagnosis.On opening the knee, all components were found to be well fixed.There was some laxity through the range of motion and a decision was made to upsize the poly insert from a size 15mm to a 20mm thereby making the knee more stable.
Event or Problem Description
Additional information received stated that the patient's soft tissue may have stretched out resulting in a looser and unstable knee.
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.H10 additional narrative: added: b5, e1 (facility name), h6 (patient).H6 patient code: no code available (3191) was used to capture joint instability.

• Brand Name: TC3 RP TIBIAL INSERT S5,15.0
• 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: 10214588
• Report Number: 1818910-2020-14752
• Device Sequence Number: 2565152
• Product Code: JDI
• UDI-Device Identifier: 10603295242512
• UDI-Public: 10603295242512
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K802627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 06/11/2020

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: 96-2363
• Device Catalogue Number: 962363
• Device Lot Number: C86982
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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 5.; PFC*SIGMA DIS AUG 8MM,SZ5,LEFT.; PFC*SIGMA TC3 FEM LEFT SZ5.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; TC3 RP TIBIAL INSERT S5,15.0.; UNIVERSAL STEM 115X12MM FLUTED.; UNIVERSAL STEM 115X16MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR