BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBILE LINER ØINT 28 MM Ø42 MM

    MDR report key: 13107553 · Received December 29, 2021

    Report

    Report Number
    3008021110-2021-00108
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    November 24, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Product Problem
    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 INVOLVED LOT NUMBERS: NO PRE-EXISTING ANOMALY ON THE 60 MOBILE LINERS RELEASED WITH LOT NUMBER 20AT5LH, STER. 2100192. NO PRE-EXISTING ANOMALY ON THE 50 HEADS RELEASED WITH LOT NUMBER 1801390, STER. 1800070 THUS WE CAN STATE THEY HAVE BEEN MANUFACTURED UP TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. A FINAL MDR WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE INVOLVED LOT NUMBERS: NO PRE-EXISTING ANOMALY ON THE 60 MOBILE LINERS RELEASED WITH LOT NUMBER 20AT5LH, STER. 2100192; NO PRE-EXISTING ANOMALY ON THE 50 HEADS RELEASED WITH LOT NUMBER 1801390, STER. 1800070. THUS, WE CAN STATE THEY HAVE BEEN MANUFACTURED UP TO SPECIFICATIONS AN IN LINE WITH THE RELEVANT TEST AND CHECKS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. THE INVOLVED DEVICES WERE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINT SOURCE, THIS EVENT IS CLASSIFIED AS NOT PRODUCT RELATED AS IT APPEARS TO BE CAUSED BY AN INTRA-OPERATIVE ERROR DURING THE ASSEMBLY OF THE DEVICES. PMS DATA: THIS IS THE ONLY SIMILAR COMPLAINT INVOLVING MOBILE LINERS (FAMILY CODES 5566.50.401 TO 580 AND 5566.54.401/420) WE ARE AWARE OF. THEREFORE, BASED ON LIMACORPORATE PMS DATA, WE ESTIMATE AN OCCURRENCE RATE OF ABOUT (B)(4). NO CORRECTIVE ACTION NEEDED FOLLOWING THIS COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY PERFORMED ON THE (B)(6) 2021. ACCORDING TO THE INFORMATION RECEIVED, THE MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420 LOT 20AT5LH, STER. 2100192) WAS DAMAGED IN THE ATTEMPT TO DISASSEMBLE IT FROM THE HEAD (FEM. MODULAR HEAD - M Ø28MM, PRODUCT CODE 5010.09.282, LOT 1801390, STER. 1800070). THE LINER-HEAD CONSTRUCT HAD IN FACT BEEN ASSEMBLED INCORRECTLY DURING THE SURGERY. THE CONSEQUENCE WAS A PROLONGATION OF THE SURGICAL TIME OF APPROXIMATELY 45/60 MINUTES. EVENTUALLY IT WAS DECIDED TO IMPLANT A 40MM MOBILE LINER (PRODUCT CODE 5566.50.401, LOT 21AT0SV, STER. 2100243) AND A CERAMIC HEAD (PRODUCT CODE 5010.42.282, LOT 1780517, STER. 1700135), WITH A SPACER (PRODUCT CODE 5885.15.510, LOT 1511476, STER. 2100161 - PRODUCT NOT MARKETED IN THE US). IN ADDITION, IT WAS REPORTED THAT THE METAL LINER FOR DUAL MOBILITY WAS MISTAKENLY NOT IMPLANTED AND THEREFORE THE PATIENT HAD TO BE REVISED FEW DAYS LATER. THE REVISION SURGERY WAS REGISTERED AS MEDICAL COMPLAINT N. (B)(4) AND REPORTED TO THE FDA BY MFR #3008021110-2021-00104. EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED DURING HIP SURGERY PERFORMED ON THE (B)(6) 2021. ACCORDING TO THE INFORMATION RECEIVED, THE SURGEON WAS HAVING DIFFICULTY WITH THE ASSEMBLY OF THE MOBILE LINER ØINT 28 MM Ø42 MM (PRODUCT CODE 5566.50.420 LOT 20AT5LH, STER. 2100192) AND THE (FEM. MODULAR HEAD - M Ø28MM, PRODUCT CODE 5010.09.282, LOT 1801390, STER. 1800070). TO OVERCOME THE DIFFICULTY, HE USED A TRIAL LINER TO "HOLD" THE IMPLANTS IN PLACE AS HE CLAMPED THEM TOGETHER, BUT THE TRIAL LINER GOT STUCK TO THE MOBILE LINER-HEAD CONSTRUCT. UPON REMOVING THE TRIAL LINER, THE MOBILE LINER WAS DAMAGED AND SCRATCHED AND NO LONGER USEABLE. THE CONSEQUENCE WAS A PROLONGATION OF THE SURGICAL TIME OF APPROXIMATELY 45/60 MINUTES. EVENTUALLY, IT WAS DECIDED TO IMPLANT A 40MM MOBILE LINER (PRODUCT CODE 5566.50.401, LOT 21AT0SV, STER. 2100243) AND A CERAMIC HEAD (PRODUCT CODE 5010.42.282, LOT 1780517, STER. 1700135), WITH A SPACER (PRODUCT CODE 5885.15.510, LOT 1511476, STER. 2100161). IN ADDITION, IT WAS REPORTED THAT THE METAL LINER FOR DUAL MOBILITY WAS MISTAKENLY NOT IMPLANTED AND THEREFORE THE PATIENT HAD TO BE REVISED FEW DAYS LATER. THE REVISION SURGERY WAS REGISTERED AS MEDICAL COMPLAINT N. 323/21 AND REPORTED TO FDA WITH REF. 3008021110-2021-00104. THE PATIENT IS FEMALE, 64 YEARS OLD. THIS EVENT OCCURRED IN GREAT BRITAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2013758 MOBILE LINER ØINT 28 MM Ø42 MM MOBILE LINER DIA.INT.28MM DIA.EXT.42MM LZO LIMACORPORATE S.P.A. 5566.50.420 20AT5LH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization