MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PSC INSERT SZ 5, 9MM
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee revision on (b)(6) 2022.Device has not been explanted.The patient experiences pain, stiffness, discomfort, and weakness.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, mdl no.3044, and pending in the eastern district of new york.Per the transfer order creating this multidistrict litigation, ¿plaintiffs¿allege that their knee or hip replacement devices¿failed prematurely because of degradation of the device¿s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.¿ because the patient has filed a suit in this multidistrict litigation, the patient appears to allege that the patient was injured as a result of premature wear of an exactech polyethylene device.
Additional Manufacturer Narrative
H6: corrected health effect, medical device, component, and investigation clinical codes.
Additional Manufacturer Narrative
Most likely underlying cause: the prosthesis wear reported in (b)(4) could not be confirmed, the device remains implanted, and potential contributions of manufacturing, user, or patient-related considerations to the reported wear could not be assessed as the devices remain implanted and no images, radiographs, or relevant clinical information was provided.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: geoff gannon ; 3523771140
• MDR Report Key: 17772772
• Report Number: 1038671-2023-02306
• Device Sequence Number: 15258707
• Product Code: JWH
• UDI-Device Identifier: 10885862305442
• UDI-Public: 10885862305442
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 5, 9MM
• Device Catalogue Number: 02-022-44-5009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/12/2024; Not provided
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 09/13/2024; 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2022
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown