MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-2013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had an initial right total knee arthroplasty on (b)(6) 2022, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
H10.D10.Concomitants -product information: 7120904 02-010-06-0320 - tru cc femoral size 2 right; 6556600 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t; 6829272 02-012-60-1440 - tru stem ext 14mm x 40mm; 6611642 02-012-60-1680 - tru stem ext 16mm x 80mm; 6291424 02-012-61-2000 - tru offset stem ext coupler, 2mm; 6805768 02-012-61-4000 - tru offset stem ext coupler, 4mm; 6970563 204-70-00 - tibial stem ext.Screw pending investigation.There is no other information available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, component code, type of investigation, investigation findings, investigation conclusions.The reason the reported event cannot be confirmed from the information provided, but may have been due to prosthesis wear.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Additionally, this device was packaged after initiation of the recall and was not packaged in a non-conforming vacuum bag.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 2, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18778723
• Report Number: 1038671-2024-00317
• Device Sequence Number: 17215685
• Product Code: JWH
• UDI-Device Identifier: 10885862304933
• UDI-Public: 10885862304933
• Combination Product (Y/N): N
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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 Catalogue Number: 02-022-44-2013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown