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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 46 months after a left knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitants: optetrak femoral aug block & screw (208-05-04, (b)(6)).Optetrak logic fit tibial tray (02-012-45-4030, (b)(6)).Optetrak logic stem extension femoral and tibial (02-012-60-1440, (b)(6)).Optetrak tibial stem extension screw (204-70-00, (b)(6)).Optetrak logic femoral component (02-010-06-0240, (b)(6)).Optetrak femoral aug block & screw (208-05-04, (b)(6)).Optetrak logic stem extension femoral and tibial (02-012-60-1440, (b)(6)).Optetrak logic femoral augment & screw posterior, cemented (02-010-06-0541, (b)(6)).Optetrak logic femoral augment & screw posterior, cemented (02-010-06-0541, (b)(6)).Smith & nephew cement restrictor depuy smartset ghv gentamicin bone cement x 4 optetrak logic femoral component (02-010-06-0240, (b)(6)).Truliant tibial insert (02-022-35-4013, (b)(6)).The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: a4, b5, g3, h6 clinical codes, component code, type of investigation, investigation findings.
Event or Problem Description
It is documented via legal documentation approximately 46 months after a revision left knee replacement surgery, the patient underwent a second revision left knee replacement surgery.The patient experienced left anterior knee pain and recurrent effusions.A revision operative report was provided pre-operative work up for infection was noted to be negative.X-rays showed loosening of patellar component with osteolysis.Intraoperatively the tibial insert, upon removal, was noted to have signs of oxidative changes.The femoral and tibial components were noted to be well fixed.The patellar component was significantly loose.The surgeon observed and noted a very thin patella with concavity.It was elected to proceed with bone grafting and not resurfacing.There were no medical or surgical interventions reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of patellar loosening or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the patella implant to the patellar bone, may have lead to loosening at the cement-bone 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.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, 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: 20048407
• Report Number: 1038671-2024-03038
• Device Sequence Number: 20822060
• 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: 2020
• 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,Followup
• Report Date (Section B): 08/13/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2024
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 07/22/2024; 08/12/2025
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 04/01/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 76 KG