MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-44-4013
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle Weakness/Atrophy (1967); Pain (1994); Scar Tissue (2060); Discomfort (2330); Joint Laxity (4526); Joint effusion (4849)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.
Event or Problem Description
It was reported via legal notification that a male patient, had an initial right knee implanted on (b)(6) 2020, and is scheduled for a revision procedure on (b)(6) 2022, approximately 2 years post op for reasons unknown.No additional information.
Event or Problem Description
Additional information via legal-revision operative report for the right knee on (b)(6) 2022 - preliminary diagnosis: mid flexion instability right total knee prostheses in the exactech recall group.Indications: 68 yo male two years post right knee arthroplasty.He has had persistent pain with recurring effusions since surgery.The clinical diagnosis has been consistent with possible mid flexion instability.Findings: thickened scarred pseudomembrane.There is thickened synovium as seen with particulate polyethylene debris.No signs of infections.All components were well fixed.Imaging studies preoperatively did not demonstrate any osteolysis.On examination under anesthesia, there was moderately varus laxity inflexion with a jog of valgus opening in flexion.Inspection of the removed polyethylene demonstrates minimal wear.A compressive sterile dressing was applied to the knee and the patient was taken to recovery in stable condition.Discharged from facility (b)(6) 2022.
Additional Manufacturer Narrative
Additional information: a2, b5, b6, h6.Health effect - clinical code & h8 pending investigation.
Additional Manufacturer Narrative
H6: investigation results: the revision reported was likely the result of polyethylene wear as stated in the operative notes.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 the polyethylene wear cannot be determined as the device was not available for evaluation, and radiographs, photographs, or operative notes were not provided.Corrected dates in section b3 and d6b.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: clinical codes, impact code, medical device problem code, types of investigation and investigation findings.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 PSC INSERT SZ 4, 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 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 3523771140
• MDR Report Key: 15535780
• Report Number: 1038671-2022-01223
• Device Sequence Number: 5212213
• Product Code: JWH
• UDI-Device Identifier: 10885862305305
• UDI-Public: 10885862305305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: 02-022-44-4013
• Device Catalogue Number: 02-022-44-4013
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 04/05/2023; 10/03/2023; 03/06/2026
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 04/26/2023; 10/12/2023; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male