BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE PEG PATELLA 32MM

    MDR report key: 21223328 · Received January 23, 2025

    Report

    Report Number
    1038671-2025-00377
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    April 25, 2023
    Report Date
    March 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039651
    PMA / PMN Number
    K932690
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    LEGAL CASE - USA (MASTER CASE. (B)(4). CASE NO. (B)(4). PATIENT ID: (B)(6). IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY, TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6) 02-012-48-3011 LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM. SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. UDI: (B)(4). 510K: K111400. CONCOMITANT PRODUCTS: (B)(6) - 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3, (B)(6) - 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, (B)(6) - 200-03-32 - ONE PEG PATELLA 32MM, (B)(6) - 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK, (B)(6) - 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19. ORIGINAL DESCRIPTION SUMMARY: LEGAL CASE - USA, PATIENT ID: (B)(6). THIS PATIENT IS VERIFIED FOR RIGHT KNEE ON DR. (B)(6) LIST. HE HAD RIGHT KNEE REVISION ON (B)(6) 2023 WITH DR. (B)(6). POSSIBLE MATCH FOUND ON THE KNEE LIST FOR DR. (B)(6). PATIENT ID: (B)(6), SURGERY/INVOICE DATE: ON (B)(6) 2013, DATE OF INSERT MANUFACTURE: 2011-08-02, SHELF LIFE AT TIME OF IMPLEMENTATION: 1 - 2, ITEM NUMBER AND FULL CORPORATE DESCRIPTION: 02-012-48-3011 - LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM, SERIAL NUMBER: (B)(6), INSERT THICKNESS: 11. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE. EBI INITIAL SURGERY ATTACHED. HISTORICAL RECORD & SMARTSOLVE SEARCHED FOR SN/PATIENT NAME WITH NO RESULTS. NO FURTHER INFORMATION. (B)(6), 02-012-48-3011 LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM. SERIAL NUMBER: (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. UDI: (B)(4), 510K: K111400. CONCOMITANT PRODUCTS: (B)(6) - 02-010-03-0330 - LOGIC CR FEMORAL CEM, RIGHT, SZ 3, (B)(6) - 02-012-45-3030 - LGC TIBIAL FIT TRAY CEM SZ 3F / 3T, (B)(6) - 200-03-32 - ONE PEG PATELLA 32MM, (B)(6) - 201-78-25 - SMALL HEADED SHARP PIN, 1 1/8" 4 PACK, (B)(6) - 203-96-42 - 11-4132 STRYKER SYS 6 90X13/21X1.19.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 119 MONTHS AFTER A RIGHT KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, SEVERE PAIN, SWELLING, AND INSTABILITY, TISSUE DAMAGE, OSTEOLYSIS, PERMANENT BONE LOSS, AND OTHER INJURIES. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084624 ONE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. ONE PEG PATELLA 32MM 10885862039651

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female