MAUDE Adverse Event Report: EXACTECH, INC. CEMENTED FINNED TIB. TRA SZ 5F/5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CEMENTED FINNED TIB. TRA SZ 5F/5T
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case ¿ usa (b)(4) patient id: (b)(6).It was reported via legal documentation that a patient had a left total knee arthroplasty on (b)(6) 2013, and then experienced revision surgical procedure on (b)(6) 2023 approximately 9 years and 5 months after initial implant.Per operative report notes (not attached): wear through the polyethylene and into the metal of the tibial tray causing significant eburnation of metallosis.Per surgeon notes: significant metallosis and erosion of the bone and significant osteolysis on both sides of the joint.No images were provided.There is no other information available.The patient has filed a short-form complaint in a multidistrict litigation titled in re: exactech polyethylene orthopedic products liability litigation, (b)(4), and pending in the eastern district of (b)(6).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.As directed by qa management: this legal complaint case is from the united states.The event did not occur in, nor is it reportable for brazil, canada, eea/eu, japan, taiwan, or great britain, excluding northern ireland.Therefore, only the us reportability determination will be assessed.
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: (b)(6), 200-75-09 - cr tibial insert sz 5, 9mm, slope ++, (b)(6), 200-04-55 - cemented finned tib.Tra sz 5f/5t, (b)(6), 230-02-05 - optetrak asy, cr cemented femoral, sz 5, (b)(6), 200-02-38 - three peg patella 38mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, d4, d6 - e codes.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 approximately 114 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of implant, metal related pathology, and osteolysis.Revision surgery operative notes were provided.Patient left the operating room in stable condition.Post operative diagnosis noted wear of the implant.No further issues or complications were reported.No additional information is available.

• Brand Name: CEMENTED FINNED TIB. TRA SZ 5F/5T
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21223775
• Report Number: 1038671-2025-00378
• Device Sequence Number: 12958410
• Product Code: JWH
• UDI-Device Identifier: 10885862039798
• UDI-Public: 10885862039798
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Expiration Date: 10/07/2014
• Device Model Number: CEMENTED FINNED TIB. TRA SZ 5F/5T
• Device Catalogue Number: 200-04-55
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/01/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 10/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown