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

Model Number	TRULIANT TIB IMP CR INS STD SZ 2, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately three years post initial tka, the 67 y/o female patient had a revision due to the device poly recall; no other reason reported.Patient was revised to exactech devices.There was no breakage of a device or a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The device is not available for evaluation due to hospital would not allow.No additional information.
Additional Manufacturer Narrative
As reported, approximately three years post initial tka, the 67 y/o female patient had a revision due to the device poly recall; no other reason reported.Patient was revised to exactech devices.There was no breakage of a device or a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The device is not available for evaluation due to hospital would not allow.No additional information.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 was reported to be due to the device recall.No other reason was provided.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, g1, h6 - clinical code, medical device problem code, component code, investigation conclusions, h7 and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, loss of mobility and prosthesis wear.As a result, the patient underwent a right knee revision approximately 3 years after initial implantation.No further patient impact reported.No further information available.

• Brand Name: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• 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: 16074871
• Report Number: 1038671-2022-01648
• Device Sequence Number: 17665484
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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 Expiration Date: 02/14/2025
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• Device Catalogue Number: 02-022-47-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 05/12/2023; 04/30/2026
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/09/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2017
• 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: THREE PEG PATELLA 29MM.; TRULIANT CR CEM FEM CR CEM RIGHT SZ 2.; TRULIANT TIB FIT TRAY CEM SZ 2F / 2T.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female