BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

    MDR report key: 20431197 · Received October 11, 2024

    Report

    Report Number
    1038671-2024-03954
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    June 28, 2024
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    UDI-DI
    10885862022066
    PMA / PMN Number
    K070479
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: "(B)(6), 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1; (B)(6), 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1; (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM; (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM; (B)(6), 190-30-03 - ALT HA S CLR STD SZ 3; (B)(6), 190-30-03 - ALT HA S CLR STD SZ 3; (B)(6), 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM; (B)(6), 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM. 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.

    Description of Event or Problem · 0

    LEGAL CASE ¿ USA (MDL NO. (B)(4)): (B)(4) IS ASSOCIATED WITH THIS CASE. THE PATIENT HAS FILED A SHORT-FORM COMPLAINT IN A MULTIDISTRICT LITIGATION TITLED IN RE: EXACTECH POLYETHYLENE ORTHOPEDIC PRODUCTS LIABILITY LITIGATION, MDL NO. (B)(4), AND PENDING IN THE EASTERN DISTRICT OF (B)(6). PER THE TRANSFER ORDER CREATING THIS MULTIDISTRICT LITIGATION, ¿PLAINTIFFS¿ALLEGE THAT THEIR KNEE OR HIP REPLACEMENT DEVICES¿FAILED PREMATURELY BECAUSE OF DEGRADATION OF THE DEVICE¿S POLYETHYLENE COMPONENT WHICH RESULTED IN THE PREMATURE REMOVAL (OR PLANNED REMOVAL) OF THE PROSTHESIS AT ISSUE.¿ BECAUSE THE PATIENT HAS FILED A SUIT IN THIS MULTIDISTRICT LITIGATION, THE PATIENT APPEARS TO ALLEGE THAT THE PATIENT WAS INJURED AS A RESULT OF PREMATURE WEAR OF AN EXACTECH POLYETHYLENE DEVICE. UNABLE TO CONFIRM SPECIFIC DEVICES DUE TO BILATERAL EBI INVOICE DATA. THE SERIAL NUMBER (B)(6) ARE CONFIRMED TO BE A PART OF RECALL NUMBER: Z-1729-2022. 130-28-51 - NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; SERIAL: (B)(6); 510K: K070479; UDI: (B)(4); PRODUCT CODE: JDI, LPH, LWJ, LZO, MEH; X-RAY: NO; OPERATIVE NOTES: NO. CONCOMITANT DEVICES: (B)(6), 186-01-48 - INTEGRIP CC, CLUSTER 48MM, G1; (B)(6), 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1; (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM; (B)(6), 180-65-30 - ALTEON 6.5MM SCREW, 30MM; (B)(6), 190-30-03 - ALT HA S CLR STD SZ 3; (B)(6), 190-30-03 - ALT HA S CLR STD SZ 3; (B)(6), 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM; (B)(6), 170-28-00 - BIOLOX DELTA FEMORAL HEAD 28MM OD, +0MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335389 NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. 10885862022066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R