MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-22-09
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation, a patient had left knee replacement on (b)(6) 2006.Their left knee revision was (b)(6) 2022, approximately 16 years 1 month after their initial procedure due to pain and discomfort.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, loss of range of motion and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface after over sixteen years of implanted use.Potential contributions of manufacturing, user, and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and product information 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: PS TIBIAL INSERTS SZ 2, 9MM
• 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: kate jacobson ; 3523782617
• MDR Report Key: 17054579
• Report Number: 1038671-2023-01228
• Device Sequence Number: 17902285
• Product Code: JWH
• UDI-Device Identifier: 10885862048226
• UDI-Public: 10885862048226
• 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: 2006
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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
• Device Expiration Date: 08/13/2011
• Device Catalogue Number: 204-22-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2006
• 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: Required Intervention
• Patient Sex: Unknown