BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM. MODULAR HEAD - M Ø32MM

    MDR report key: 16732885 · Received April 13, 2023

    Report

    Report Number
    3008021110-2023-00031
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 7, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    LZO
    PMA / PMN Number
    K141327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOTS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE OVERALL NUMBER. THEREFORE, WE CAN ENSURE THAT ALL THE PRODUCTS PLACED ON THE MARKET WITH THESE LOTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. STER. LOT #1800201 WAS ASSOCIATED TO ONE OTHER COMPLAINT BUT WAS NOT RELATED TO INFECTION. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #'S ASSOCIATED TO AN INFECTION. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WAS REQUESTED TO THE COMPLAINT SOURCE BUT WAS NOT AVAILABLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF DELTA-TT ACETAB.CUP - BELONGING TO THE FAMILY CODES 5552.15.XXX - DUE TO INFECTION IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL REPORT.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2023. SURGEON REMARKS FOUND INFECTION. EVERYTHING REMOVED. COMPONENTS EXPLANTED. H-MAX S LATERAL. FEM. STEM #12 COMMERCIAL CODE #4251.20.120 - LOT #1807776 - STER. #1800201. FEM. MODULAR HEAD - M Ø32MM COMMERCIAL CODE #5010.42.322 - LOT #2082253 - STER. #2000267 . DELTA-TT ACETAB.CUP Ø52 MM COMMERCIAL CODE #5552.15.520 - LOT #2103410 - STER. #2100123. DELTA NEUTR.LINER ØINT 32MM #M COMMERCIAL CODE #588551158 - LOT#2116478 - STER. #2100294. WASHED OUT. SPECIMEN WAS TAKEN BUT RESULTS NOT AVAILABLE AT THIS TIME. IMPLANTED DELTA TT ACETAB.CUP Ø56 MM AND CERAMIC 40 LINER. INITIAL SURGERY -(B)(6) 2022. PATIENT - MALE. AGE - 66. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027347 FEM. MODULAR HEAD - M Ø32MM FEM. MODULAR HEAD - M Ø32MM LZO LIMACORPORATE S.P.A 5010.423.22 2082253

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention