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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Rupture (2208); Discomfort (2330); Muscle/Tendon Damage (4532)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that on (b)(6) 2022 the patient was revised and then approximately 7 months later the patent experienced a surgical procedure with device exchange on (b)(6) 2023.Revision op report of (b)(6) 2023- postoperative diagnosis- patellar rupture from the patella.Procedure 1.Revision, total knee 2.Repair of patellar tendon with graft technique.Patient with pain and discomfort of her knee, loss of extension.It was noted that the patellar tendon ¿was freed from the distal pole of the patella and not functioning¿.Revision of femur, although it was not loose.Grafts for patella tendon were put in place.A long leg cast was applied with knee complete extension.The patient was taken to recovery room in good condition.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D10.Concomitants: 5425662, 02-012-45-2010 - lgc tibial fit tray cem sz 2f / 1t.5814298, 02-012-50-1014 - tru tib aug 1/2 rl sz 1, 10mm.6262859, 02-012-50-1013 - tru tib aug 1/2 rm sz 1, 10mm.7032388, 02-012-60-1440 - tru stem ext 14mm x 40mm.7103914, 02-012-66-2000 - metaphyseal tibial cone, ml32mm.7213340, 652-00-02 - optecure with ccc - 2cc.H3.Investigation results - the cause of the patient¿s patellar tendon rupture cannot be conclusively determined, as the cause of the tendon rupture was not indicated; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient had a first right knee revision seven months prior to this surgical procedure.There is no mention of device malfunction or wear in the revision operative report.Per ifu information -patients should be informed that their weight and activity level may affect the longevity of the implant.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d4 (remove all from initial report-suspect device unknown), h6: clinical codes, component code and type of investigation.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
• MDR Report Key: 19020794
• Report Number: 1038671-2024-00711
• Device Sequence Number: 11732464
• Product Code: JWH
• UDI-Device Identifier: 10885862314284
• UDI-Public: 10885862314284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160484
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 12/18/2025

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: 05/19/2026
• Device Catalogue Number: 200-07-32
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female