BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    MDR report key: 19418329 · Received May 29, 2024

    Report

    Report Number
    1038671-2024-01556
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    June 21, 2023
    Report Date
    February 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES 162-00-03 - NECK PRESERVING STEM, STD OFFSET PLASMA SZ 3 2687534 170-32-93 - BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM 2299618 186-01-50 - INTEGRIP CC, CLUSTER 50MM, G1 2791286 620-00-02 - PLATELET RICH PLASMA KIT WITH SPRAY TIPS 129427 620-12-02 - ACCELERATE PRP 60 ML & ACD-A A20129017. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL Z-1732-2022; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. 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

    MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE MOST LIKELY UNDERLYING CAUSE FOR THE REVISION REPORTED IN CASE (B)(4) IS PROSTHESIS WEAR AND A COMBINATION OF RISK FACTORS SPECIFIED SUCH AS USE ERROR, IMPLANT POSITIONING, IMPLANT SIZE SELECTION, AND PATIENT FACTORS (FITNESS FOR SURGERY, BIOMECHANICS, ACTIVITY LEVEL AND LOCAL TISSUE OXIDATION POTENTIAL). HOWEVER, THIS CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION AND 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.".

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 117 MONTHS AFTER A RIGHT TOTAL HIP REPLACEMENT, A PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS POLYETHYLENE WEAR, PAIN AND OSTEOLYSIS. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION, NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660402 NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization| R SEE H10