BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAND. ACETAB. CEM. CUP Ø48MM

    MDR report key: 17069156 · Received June 6, 2023

    Report

    Report Number
    3008021110-2023-00069
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    May 9, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE CEMENTED CUPS THAT WERE RELEASED WITH LOT NUMBER 1211582. THIS IS THE FIRST AND COMPLAINT RECEIVED ON THIS LOT NUMBER. WE WILL SUBMIT A FINAL REPORT AFTER THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE CEMENTED CUPS THAT WERE RELEASED WITH LOT NUMBER 1211582. THE RAW MATERIAL CERTIFICATE WAS ALSO CHECKED WITHOUT DETECTING ANY DEVIATION. ACCORDING TO OUR RECORDS, AT LEAST 52 CUPS BELONGING TO LOT 1211582 HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. THE FOLLOWING X-RAYS WERE PROVIDED BY THE COMPLAINT SOURCE: X-RAYS DATED (B)(6) 2014. X-RAYS DATED (B)(6) 2014. X-RAYS DATED (B)(6) 2014. X-RAYS DATED (B)(6) 2015. X-RAYS DATED (B)(6) 2018. X-RAYS DATED (B)(6) 2019. X-RAYS DATED (B)(6) 2022. X-RAYS DATED (B)(6) 2022. X-RAYS EVALUATION WAS REQUESTED TO OUR MEDICAL CONSULTANT. HE COMMENTED THAT THE CUP IMPLANTED IN 2014 WAS NOT A HIGHLY CROSSLINKED POLYETHYLENE AND THAT "STARTING IN 2018 ABRASION CAN BE NOTED, PROGRESSING RAPIDLY. THE AGGRESSIVE PE DEBRIS LEAD TO DEFINITE LOOSENING IN 2020. LOOSENING OF THE CUP IS CLEARLY EVIDENT, THE STEM MOST LIKELY AS WELL. REVISION WAS WELL INDICATED AND PERFORMED SUFFICIENTLY." THE EXPLANTED DEVICES WERE NOT RETURNED FOR INVESTIGATION, THEREFORE NO SPECIFIC ANALYSIS COULD BE PERFORMED ON THEM. BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE REPORTED ISSUE. THE X-RAYS ANALYSIS CONFIRMED THE LOOSENING OF THE CUP AND POLYETHYLENE WEAR OVER THE YEARS. WITHOUT THE POSSIBILITY TO ANALYZE THE DEVICE, NO FURTHER ANALYSIS CAN BE PERFORMED, OTHER THAN THE CHECK OF THE DEVICE HISTORY RECORDS AND RAW MATERIAL CERTIFICATE, WHICH CONFIRMED THE ABSENCE OF PRE-EXISTING ANOMALIES ON THE INVOLVED LOT NUMBER. IN CONCLUSION, WE CAN STATE THAT THE INVOLVED DEVICE HAS BEEN MANUFACTURED UP TO SPECIFICATIONS AND IN LINE WITH RELEVANT TESTS AND CHECKS. THIS EVENT IS THEREFORE CLASSIFIED AS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF CEMENTED CUPS (FAMILY CODES 5615/16/18/19/20/22/26.50.XXX) DUE TO DISLOCATION AND/OR LOOSENING IS ABOUT 0,01% NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISLOCATION, INSTABILITY AND PAIN. EXCESSIVE POLYETHYLENE ABRASION WAS REPORTED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, THE PREVIOUS SURGERY ON (B)(6) 2014. THE PATIENT IS FEMALE, 75 YEARS OLD, 80 KG. THIS EVENT OCCURRED IN CZECH REPUBLIC.

    Description of Event or Problem · 0

    HIP REVISION SURGERY DUE TO DISLOCATION, INSTABILITY AND PAIN. EXCESSIVE POLYETHYLENE ABRASION WAS REPORTED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2022, THE PREVIOUS SURGERY ON (B)(6) 2014. THE PATIENT IS FEMALE, 75 YEARS OLD, 80 KG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674616 STAND. ACETAB. CEM. CUP Ø48MM CEMENTED CUPS (UHMWPE) DIA. 48 FOR HEAD DIA28MM, LPH LIMACORPORATE S.P.A. 5618.50.020 1211582

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention