BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED PATELLA 29M 3 PEG IMPLANT

    MDR report key: 20048407 · Received August 23, 2024

    Report

    Report Number
    1038671-2024-03038
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 22, 2024
    Report Date
    August 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314277
    PMA / PMN Number
    K160484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071297 ADVANCED PATELLA 29M 3 PEG IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314277

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H SEE H11