MAUDE Adverse Event Report: EXACTECH, INC. INSET PATELLA 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-05-26
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for the revision reported in (b)(4) may be the result of prosthesis wear, femoral loosening, and tibial loosening, or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component and the tibial construct to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.D10: logic pts, size 4, 8mm (cat# 02-012-42-4008 / serial# (b)(6)); fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6)); tibial augment block 1/2-sz 4 5mm (cat# 204-64-05 / serial# (b)(6)); tibial augment block 1/2-sz 4 5mm (cat# 204-64-05 / serial# (b)(6)); tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(6)).
Event or Problem Description
As reported, approximately 5 years and 3 months post the initial right total knee arthroplasty, the patient presented back to surgeon's office with complaints of their knee.Upon examination, poly wear and osteolysis was evident.The patient was scheduled for a revision right total knee arthroplasty, possible poly swap.The patient underwent a full knee revision to competitor's products.The poly showed early wear and the metal implants were loose on the bone.There was no reported breakage of a device.There was a greater than 45 minutes surgical delay, but there were no adverse events as a result.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported may be the result of prosthesis wear, femoral loosening, and tibial loosening, or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component and the tibial construct to the respective bone, may have lead to loosening at the cement-implant interface; however, this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical 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: INSET PATELLA 26MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21504070
• Report Number: 1038671-2025-01354
• Device Sequence Number: 4400387
• Product Code: JWH
• UDI-Device Identifier: 10885862039842
• UDI-Public: 10885862039842
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• 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): 03/06/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 200-05-26
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2012
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male