MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-3011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement (b)(6) 2020.They underwent right knee revision on (b)(6) 2022, approximately 1 year 11 months after their initial procedure.(b)(6) 2022 op report states that there was found to be a clean wound with clear synovial joint fluid and well-fixed femoral, tibial, and patellar components.There was a mild to moderate amount of visible polyethylene wear within the tibial polyethylene.There was also evidence of a mild amount of polyethylene debris within synovial encapsulation.The patient was awakened and transferred to recovery in stable condition.There were no complications.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: 6449567, 02-020-12-0330 - truliant ps por fem ps por right sz 3.6338559, 02-022-55-3030 - truliant por tib tray size 3f/3t.6546974, 200-02-32 - three peg patella 32mm.S088630, 521-78-23 - threaded pin size 2.3 collared 2pk.S088637, 521-78-23 - threaded pin size 2.3 collared 2pk.8034720103, a10012 - gps implant kit v2.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of this prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b3, h6 - health effect - clinical code, component code, type of investigation, investigation findings, h7 and h9.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523782617
• MDR Report Key: 17240023
• Report Number: 1038671-2023-01516
• Device Sequence Number: 4872039
• Product Code: JWH
• UDI-Device Identifier: 10885862304278
• UDI-Public: 10885862304278
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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
• Device Model Number: 02-022-35-3011
• Device Catalogue Number: 02-022-35-3011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 04/21/2026
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 01/11/2024; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female