MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS STD SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-47-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530); Implant Pain (4561)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report numbers: 1038671-2024-03688, 1038671-2024-03689 d10 concomitants: (b)(6) 02-022-47-2009 - truliant tib imp cr ins std sz 2, 9mm.(b)(6) - 00-5071-129-00 - 105x19.5x1.27mm.E1: phone number (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-03688, 1038671-2024-03689.The reason for the patient¿s second revision reported was likely the result of loosening between the tibial and femoral implants and the bone after almost 11 years of implantation.Osteolysis, and possibly loosening, on both the tibial and femoral sides appears to have been present at the time of the first revision.As the tibial insert had been recently revised, the articular surface damage is likely consistent with third-body wear secondary to loosening and non-articular damage secondary to femoral subsidence.However, this cannot be confirmed as the devices were not returned.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported, approximately 10 months post the previous revision surgery, the patient had knee pain and the surgeon decided to revise again because the femoral and tibial components had been found to be loose.The patient experienced implant pain and osteolysis.Metallosis was found and all proliferative tissue removed, then all components were replaced to competitor devices.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• 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: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 20902550
• Report Number: 1038671-2024-04754
• Device Sequence Number: 13013274
• Product Code: JWH
• UDI-Device Identifier: 10885862306272
• UDI-Public: 10885862306272
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-47-2009
• 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: 09/09/2024
• Initial Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 12/29/2021
• 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 H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female