MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 3F/2T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-04-32
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Date of Event	01/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal notification the patient had an initial right total knee arthroplasty.Approximately six (6) years later, the patient underwent a right knee revision procedure to address osteolysis, aseptic loosening of the tibial components and development of complex regional pain syndrome secondary to polyethylene wear.Additionally, it was noted that despite undergoing revision surgery the patient experiences daily knee pain and discomfort which limit the patient's activities of daily living and recreation and impacts the patient's quality of life.The patient has suffered and continues to suffer permanent and debilitating injures and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; metallosis; soft tissue damage; infection; and other injuries presently undiagnosed, which all require ongoing medical care.No additional information is available.
Additional Manufacturer Narrative
D10: exactech tibial tray, catalog no.204-04-32, lot no.2199394; and exactech femoral component, catalog no.234-03-03, lot no.1546557.H10: multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-00509.The revision reported in this event may have been the result of polyethylene liner wear leading to osteolysis and aseptic tibial loosening as stated in the legal documentation.The loosening may have been the result of an insufficient bond between the tibial tray and the bone.The extent of the reported polyethylene wear and osteolysis cannot be determined as the devices were not available for evaluation and images of explanted devices, pre-revision radiographs, and operative notes were not provided.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 3F/2T
• 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: 24262352
• Report Number: 1038671-2026-00118
• Device Sequence Number: 18628871
• Product Code: JWH
• UDI-Device Identifier: 10885862047656
• UDI-Public: 10885862047656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 12/06/2016
• Device Catalogue Number: 204-04-32
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 12/08/2011
• 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: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female