MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	204-25-09
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Unspecified Musculoskeletal problem (4535); Aseptic loosening (4883)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 1111755 200-02-41 - three peg patella 41mm.1931520 234-02-05 - optetrak asy,ps cemented femoral, sz 5, 2059194 204-04-55 - trapezoid tibial tray sz 5f/5t.Correction/removal number: z-0019-2022.
Event or Problem Description
As reported by legal notification, the male patient had an initial left tka on (b)(6) 2011.The patient underwent revision surgery on (b)(6) 2018 secondary to complete polyethylene liner wear and delamination liner with resulting synovitis, cyst formation, osteolysis of the femur and tibia, and aseptic loosening of the femoral and tibial components.No other patient information/medical history reported.
Additional Manufacturer Narrative
The revision reported may have been the result of loosening and prosthesis wear.The aseptic (non-infected) femoral and tibial loosening was likely the result of insufficient bond between the components and bone.The tibial insert wear may have been due to malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not available for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, f10 (remove erroneous entries from initial report), g2, h6: clinical codes, component code, type of investigation findings and investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: PS TIBIAL INSERTS SZ 5, 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16633082
• Report Number: 1038671-2023-00531
• Device Sequence Number: 12557676
• Product Code: JWH
• UDI-Device Identifier: 10885862048462
• UDI-Public: 10885862048462
• 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: 2011
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: 03/28/2016
• Device Model Number: 204-25-09
• Device Catalogue Number: 204-25-09
• 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: 03/01/2024; 04/10/2026
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 03/18/2024; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2008
• 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