MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-25-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitant devices: 1458378 200-02-38 - three peg patella 38mm; 1220303 204-04-55 - trapezoid tibial tray sz 5f/5t; 1455786 204-34-02 - fluted stem extension 25l x 14 mm; 1494355 204-70-00 - tibial stem ext.Screw; 1417176 234-02-05 - optetrak asy,ps cemented femoral, sz 5.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, prosthesis wear, a failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain, and/or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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.
Event or Problem Description
As reported via legal documentation, this patient had left knee replacement surgery on (b)(6) 2009.He had left knee revision on (b)(6) 2023, approximately 13 years 5 months after their initial implantation.He has developed progressive pain and debilitation related to his left knee.His x-rays showed what appeared to be loosening of the femoral component with debonding of the anterior flange with the cement mantle.The patellar component was well fixed however was severely worn and therefore, replaced.The femoral component had significant debonding of the cement prosthetic interface under the anterior flange and was easily removed.There also appeared to be loosening of the tibial component as it was removed from its cement mantle relatively easily.The polyethylene liner had minimal wear except for on the anterior portion of the tibial spine.There was synovial hypertrophy consistent with component loosening.It was reported that the patient has experienced prosthesis wear, discomfort, pain, synovitis, osteolysis.No further issues or complications were reported.No additional information is available.

• Brand Name: PS TIBIAL INSERTS SZ 5, 13MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20663156
• Report Number: 1038671-2024-04357
• Device Sequence Number: 18268423
• Product Code: JWH
• UDI-Device Identifier: 10885862048486
• UDI-Public: 10885862048486
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2024

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: 05/31/2008
• Device Catalogue Number: 204-25-13
• 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: 04/20/2023
• Initial Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 06/05/2003
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male