MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 32MM 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-07-32
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-020-11-0230 - truliant ps cem fem ps cem left sz 3, (b)(6), 02-020-11-0330 - truliant ps cem fem ps cem right sz 3, (b)(6), 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm, (b)(6), 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm, (b)(6), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t, (b)(6), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t, (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant, (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant, (b)(6), 02-029-99-1001 - fluted headless pin 3.0" square head.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-01051, 1038671-2024-03119.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately 62 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear and aseptic loosening of the femoral component.Approximately 6-9 months prior to revision, the patient began experiencing increased stiffness, pain, and swelling.Radiographs showed possible radiolucency at the end of the femoral component, but otherwise no gross obvious signs of wear.Revision surgery operative notes were provided.Findings also indicated significant scar tissue, damage on the lateral facet of the patella, significant yellow coloration of the medial articular surface of the polyethylene with some brittleness, and an osteolytic cyst on the medial condyle of the femur.The surgeon performed a revision left total knee arthroplasty of femoral, tibial, and patellar components.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.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 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: ADVANCED PATELLA 32MM 3 PEG IMPLANT
• 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: 21576571
• Report Number: 1038671-2025-01547
• Device Sequence Number: 12996939
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• 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,Followup
• Report Date (Section B): 03/13/2025

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?: Yes
• Device Catalogue Number: 200-07-32
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 107 KG