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

Catalog Number	200-07-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
" d10: 02-012-60-1425 - tru stem ext 14mm x 25mm; 02-020-11-0320 - truliant ps cem fem ps cem right sz 2; 02-022-35-2009 - truliant tib imp ps insert sz 2 9mm; 02-022-35-2009 - truliant tib imp ps insert sz 2 9mm; 02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t; 204-70-00 - tibial stem ext.Screw.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01675.The reason for the revision reported may be the result of femoral loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the 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.".
Event or Problem Description
As reported, approximately 5.5 years post initial right side tka, the 37 y/o female patient complained of pain.Patient had a revision due to loose femur, prosthetic wear and recalled poly and due to recall surgeon used competitor's device for revision.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-ray and images received.The device is not available for evaluation due to recall hospital will not release.

• Brand Name: ADVANCED PATELLA 29M 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21459436
• Report Number: 1038671-2025-01204
• Device Sequence Number: 18120947
• Product Code: JWH
• UDI-Device Identifier: 10885862314277
• UDI-Public: 10885862314277
• 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: 2018
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 02/25/2025

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: 12/10/2022
• 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: 06/28/2023
• Initial Report FDA Received Date: 02/25/2025
• Date Device Manufactured: 12/11/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Female