BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER #L FOR MOBILE LINER Ø42

    MDR report key: 13169047 · Received January 5, 2022

    Report

    Report Number
    3008021110-2021-00110
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    December 22, 2021
    Report Date
    May 17, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LZO
    PMA / PMN Number
    K181491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE DHR OF THE INVOLVED LOT #2104874, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS THAT WERE RELEASED ON THE MARKET WITH THE SAME LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#: 2104874, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 15 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 12 OUT OF 15 LINERS WITH LOT#: 2104874 - STER. 2100144 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT#. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED DATED: ON (B)(6) 2021, HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "INDEED THE SURGEON IS RIGHT THAT THE CUP HAS BEEN IMPLANTED INCORRECTLY DURING PREVIOUS REVISION. POSITION IS TOO VERTICAL AND POSSIBLY ALSO FALSELY ANTEVERTED. DISLOCATION SUCH WAS NOT A SURPRISE. I BELIEVE (WITHOUT KNOWING THE POST OP X-RAY) DID A GOOD JOB BY IMPROVING STABILITY WITH A 20° +5MM SPACER, COMBINING IT WITH A DOUBLE MOBILITY INSERT. GIVEN THAT THE CUP ITSELF ALREADY WAS FIRMLY FIXED AND LOOSENING COULD BE EXCLUDED THIS CORRECTIVE ACTION MOST LIKELY WAS THE BEST HE COULD DO, AND NO MORE DISLOCATIONS SHOULD BE EXPECTED". CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT#: 2104874; ACCORDING TO THE MEDICAL CONSULTANT "POSITION IS TOO VERTICAL AND POSSIBLY ALSO FALSELY ANTEVERTED"; WE CAN STATE THAT THE EVENT WAS SURGICAL-FACTOR RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF LINERS FOR MOBILE LINERS - BELONGING TO THE FAMILY CODES 5885.09.040 AND 5885.09.042, DUE TO DISLOCATION 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 FINAL MDR.

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE PATIENT ROLLED OVER IN BED AFTER SURGERY WHEN THE HIP DISLOCATED. THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE 5885.09.042, LOT #2104874 - STER. 2100144) WAS EXPLANTED, ALONG WITH COMPETITOR'S FEMORAL HEAD AND ADAPTOR METAL SLEEVE. NEW COMPONENTS WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A MALE, (B)(6). EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    HIP REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO IMPLANT DISLOCATION. IT WAS REPORTED THAT THE PATIENT ROLLED OVER IN BED AFTER SURGERY WHEN THE HIP DISLOCATED. ACCORDING TO THE REPORTED INFORMATION, SURGEON BELIEVED THE REVISION CUP WAS INCORRECTLY POSITION. THE LINER #L FOR MOBILE LINER Ø42 (PRODUCT CODE: 5885.09.042, LOT#: 2104874 - STER. 2100144) WAS EXPLANTED, ALONG WITH COMPETITOR'S FEMORAL HEAD AND ADAPTOR METAL SLEEVE. NEW LINER WITH 20 DEGREE, 5MM SPACER AND DUAL MOBILITY INSERT WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. A COMPETITOR'S IMPLANT WAS REVISED: THE LINER, THE CERAMIC HEAD AND THE ADAPTER WERE IMPLANTED THEN. NO FURTHER DETAILS ARE AVAILABLE ON THE REVISION. PATIENT IS A MALE, 72 YEARS OLD. IT WAS REPORTED HE WAS COMPLAINT TO POST-OPERATIVE INDICATIONS. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589835 LINER #L FOR MOBILE LINER Ø42 LINER #L FOR MOBILE LINER DIA.42 LZO LIMACORPORATE S.P.A. 5885.09.042 2104874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other