MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 5, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PSC INSERT SZ 5, 10MM
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation or Postural Difficulties (2544); Implant Pain (4561); Crepitus (4893)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately two years post initial tka, the male patient had a revision for an unknown reason.No additional information available.
Additional Manufacturer Narrative
As reported, approximately two years post initial tka, the male patient had a revision for an unknown reason.No additional information available.There is no specific device information provided.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1, b2, b5, g2, h6 (clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions) concomitants: (b)(6) 02-010-06-0250 - logic cc femoral size 5, left, (b)(6) 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, (b)(6) 02-012-60-1880 - logic stem ext 18mm x 80mm, (b)(6) 02-012-60-2080 - logic stem ext 20mm x 80mm, (b)(6) 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6) 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6) 201-78-81 - 3" trocar, mod.Hex 2pk, (b)(6) 204-70-00 - tibial stem ext.Screw, (b)(6) 208-05-05 - cc distal fem augment sz 5, 5mm, (b)(6) 208-06-05 - cc distal fem augment sz 5, 10mm.
Event or Problem Description
Additional information received reported that the device was implanted in the left knee.The patient suffered and continues to suffer permanent and debilitating injuries and damages, including, but not limited to severe joint pain, limited range of motion, loss of mobility, crepitus, revision surgery, and other injuries presently undiagnosed, which all require ongoing medical care.The patient also suffered from anxiety and emotional distress as a direct result of the injuries.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, e.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and loss of range of motion or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: b1, b2, g1, h6: clinical code, impact code, medical device problem code, type of investigation,investigation findings, investigation conclusion.The revision reported was likely the result of loss of range of motion and prosthesis wear of their polyethylene component.The cause of the observed wear cannot be confirmed but may be related to bone and/or bone cement overhang of the femoral component.However, loss of range of motion and the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as pre-operative radiographs were not provided for evaluation.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 5, 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16604169
• Report Number: 1038671-2023-00495
• Device Sequence Number: 14666357
• Product Code: JWH
• UDI-Device Identifier: 10885862305459
• UDI-Public: 10885862305459
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/26/2026

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: TRULIANT TIB IMP PSC INSERT SZ 5, 10MM
• Device Catalogue Number: 02-022-44-5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 02/01/2024; 05/06/2025; 02/25/2026
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 08/22/2023; 01/13/2025; 05/07/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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: 3" TROCAR, MOD. HEX 2PK (3); CC DISTAL FEM AUGMENT SZ 5, 10MM; CC DISTAL FEM AUGMENT SZ 5, 5MM; LGC TIBIAL FIT TRAY CEM SZ 5F / 5T; LOGIC CC FEMORAL SIZE 5, LEFT; LOGIC STEM EXT 18MM X 80MM; LOGIC STEM EXT 20MM X 80MM; SEE H11; TIBIAL STEM EXT. SCREW
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Sex: Male