MAUDE Adverse Event Report: EXACTECH, INC. PS TIBIAL INSERTS SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	204-24-11
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.
Event or Problem Description
It was reported that this 76 y/o male patient's right knee was revised approximately 7 years 10 months post op.Patient had loosening, pain, and decrease in joint function.Operation concluded ps to competitors constrain to tibia, patella, and femur findings.There was gross lysis of femur, tibia and patella with uncontained posterior tibial and femoral, wear of poly bearing with symmetrical bilateral loss and disengagement from baseplate, no evidence of infection but large effusion and granulomatous synovitis.There was loosening of patella but femur and tibia still well fixed - components not damaged.Metal seen on xray posteromedial tibial baseplate plug.Patient revised to competitors devices.
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 following sections were updated: h6.The following sections were corrected: b2.H6.The reason for the revision reported may have been the result of patella loosening and tibial insert wear.Wear of the insert may have allowed for its reported disassembly from the tray.However, the reported loosening, wear, and disassembly could not be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.Based on the event description, it is unclear if a screw hole cover on the tray may have also become disassembled.This could possibly be due to the cover not being fully seated at the time of the index surgery.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 4, 11MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20140377
• Report Number: 1038671-2024-03292
• Device Sequence Number: 20682193
• Product Code: JWH
• UDI-Device Identifier: 10885862048394
• UDI-Public: 10885862048394
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 10/27/2016
• Device Catalogue Number: 204-24-11
• 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: 08/20/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male