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

Model Number	N/A
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right revision on (b)(6) 2022.This device has not been explanted.The patient has suffered the following injuries and complications: joint pain, joint swelling and stiffness.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.The patient has filed a 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
Pending investigation.
Additional Manufacturer Narrative
Corrected information: h6 - health effect/clinical codes, medical device problem code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d4: model number.The reason for the reported event cannot be confirmed from the information provided but may have been due to prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation 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 updated: a2, a3, d4: expiration date.D10 concomitants: (b)(6) 02-010-03-0350 - logic cr femoral cem, right, sz 5.(b)(6) 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t.(b)(6) 200-02-35 - three peg patella 35mm.E1-phone number, g1, h4, h6, h8.The following sections were corrected: b1, b2, b3: date of event n/a, d1, d4, g4, h6.The reason for the reported event cannot be confirmed from the information provided but may have been due to prosthesis wear.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation 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.

• Brand Name: TRULIANT TIB IMP CRC 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 ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17868326
• Report Number: 1038671-2023-02448
• Device Sequence Number: 14874519
• Product Code: JWH
• UDI-Device Identifier: 10885862307873
• UDI-Public: 10885862307873
• 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,Followup
• Report Date (Section B): 01/03/2025

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: N/A
• Device Catalogue Number: 02-022-51-5009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/14/2024; 01/02/2025; 01/02/2025
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/15/2024; 01/03/2025; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male