MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	PS TIBIAL INSERTS SZ 3, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that the patient, underwent initial total knee replacement surgery on her left knee on (b)(6) 2010.In the years following the surgery, the patient experienced pain, swelling, instability, and bone loss in her left knee caused by early and accelerated polyethylene wear and/or component loosening.On (b)(6) 2021, approximately 10 years 3 months post initial procedure, patient underwent an extensive revision surgery on her left knee.No device return anticipated due to this being a legal case.
Additional Manufacturer Narrative
Common device name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants medical products: 1810444, 200-02-32 - three peg patella 32mm.1623511, 200-04-32 - cemented finned tib.Tra sz 3f/2t.1849066, 234-02-03 - optetrak asy,ps cemented femoral, sz 3.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: the revision reported in the case may have been the result of polyethylene wear and loosening as stated in the legal documentation and operative notes.The aseptic (non-infected) loosening may have been the result of both patient-related conditions and insufficient bonds between the implants and the bones.The extent and root cause of the reported polyethylene wear cannot be determined as the explanted devices were not returned for evaluation, and radiographs, photographs, and operative notes were not provided.

• Brand Name: OPTETRAK
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16584084
• Report Number: 1038671-2023-00465
• Device Sequence Number: 11171495
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2017
• Device Model Number: PS TIBIAL INSERTS SZ 3, 11MM
• Device Catalogue Number: 204-23-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 06/17/2026
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 09/13/2023; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2009
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown