MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-24-09
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330); Osteolysis (2377); Balance Problems (4401); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal notification, the male patient had an initial right tka on (b)(6) 2012.The patient underwent revision surgery on (b)(6) 2017 secondary to polyethylene liner wear resulting in extensive osteolysis, synovitis, and aseptic loosening of the tibial component.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical devices: exactech tibial tray, catalog no.204-04-44, lot no.2070502; and exactech femoral component, catalog no.30-03-04, lot no.2035631.Correction/removal number: z-0019-2022.
Additional Manufacturer Narrative
H3: the revision reported may have been the result of polyethylene liner wear, osteolysis, and aseptic tibial loosening as stated in the legal documentation.The aseptic (non-infected) tibial loosening may have been the result of an insufficient bond between the tibial tray and the bone.The extent and root cause of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and radiographs, photographs, and operative notes were not provided.
Additional Manufacturer Narrative
1038671-2025-00537 multiple mdr reports were filed for this event, please see associated report: 1038671-2025-00537.This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation, investigation findings, investigation conclusions).The following sections were corrected: h6 (health effect - clinical code, medical device problem code, component code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and tibial loosening.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 and radiographs 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: CR TIBIAL INSERT SZ4, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16632994
• Report Number: 1038671-2023-00528
• Device Sequence Number: 7243716
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• 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: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2019
• Device Model Number: 200-24-09
• Device Catalogue Number: 200-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 01/28/2025
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 08/15/2023; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2011
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male