MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	PS TIBIAL INSERTS SZ 2, 13MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal document, the 80 y/o female patient underwent total arthroplasty of the left knee in (b)(6) 2013 for the treatment of osteoarthritis, the prosthesis manufactured by exactech, model optetrak, was placed, the patient evolved with premature wear of the polyethylene, with the intense osteolysis around the femoral and tibial components, culminating in the loosening of the prosthesis and now requiring the replacement of components for revision components.In march 2022, the company itself released a worldwide recall for this type of implant, alleging a defect in the packaging, which allowed the polyethylene to come into contact with oxygen and undergo oxidation, which would lead to its premature wear, with all the consequences.On (b)(6) 2023, patient was submitted to revision of the total prosthesis of the left knee, with the removal of all components, intense wear of the polyethylene verified, with delamination pattern, with the breakage of the post.Surgeon observed intense osteolysis, cavitary in the proximal tibia, patella and distal femur, being the lateral epicondyle absent.Patient was revised to competitor's device.As an intercurrence, surgeon reported the longitudinal fracture of the distal femur, which cracked during the placement of the sleeve, like 2 cerclanges per surgeon "it was a great surgery".
Additional Manufacturer Narrative
Implanted date was on (b)(6) 2013, bot exact date available.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, prosthesis fracture, and femoral and tibial loosening after 9 years of implantation.The contributions of each to the sequence of events and/or 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.Corrected fields: h6 clinical code, h6 problem code.

• Brand Name: PS TIBIAL INSERTS SZ 2, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16582289
• Report Number: 1038671-2023-00462
• Device Sequence Number: 4694411
• Product Code: JWH
• UDI-Device Identifier: 10885862048240
• UDI-Public: 10885862048240
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 05/04/2017
• Device Model Number: PS TIBIAL INSERTS SZ 2, 13MM
• Device Catalogue Number: 204-22-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female