MAUDE Adverse Event Report: EXACTECH, INC. ADVANCED PATELLA 29M 3 PEG IMPLANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	N/A
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526); Implant Pain (4561)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: 5179340 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.4992437 02-020-13-0315 - truliant cr cem fem cr cem right sz 1.5.4941842 200-07-29 - advanced patella 29m 3 peg implant.These devices are used for treatment not diagnosis, pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2018.Approximately 4 years and 3 months after the initial procedure the patient had a right knee revision on 29 apr 2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The patient has filed a complaint in a coordinated action in alachua county with master case no.2022 ca 002670.The consolidated long form complaint that applies to cases filed in this coordinated action alleges that patients filing suits in this coordinated action were required ¿to undergo revision surgeries due to severe, pain, swelling, and instability¿ due to ¿wear of the polyethylene components and resulting component loosening and/or other failure failures causing serious complications including tissue damage, osteolysis, permanent bone loss, and other injuries.¿ because the patient has filed a short-form complaint in this coordinated action, the patient appears to allege that the patient was injured as a result of wear of an exactech polyethylene device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Serial number (b)(6) is confirmed to not have been affected by the recall.D10 concomitants: (b)(6) 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t.(b)(6) 02-020-13-0315 - truliant cr cem fem cr cem right sz 1.5.(b)(6) 02-012-47-1509 - logic cr tib insert std, sz 1.5, 9 mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening 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 and radiographs 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 29M 3 PEG IMPLANT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17801508
• Report Number: 1038671-2023-02336
• Device Sequence Number: 17815502
• Product Code: JWH
• UDI-Device Identifier: 10885862314277
• UDI-Public: 10885862314277
• 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: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 200-07-29
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female