BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER FOR METAL-BACK (UHMWPE) LINER SMALL

    MDR report key: 17378663 · Received July 24, 2023

    Report

    Report Number
    3008021110-2023-00087
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    July 7, 2023
    Report Date
    July 24, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    PHX
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1212787, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. EXPLANTS ANALYSIS: THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. STILL, A PICTURE OF THE EXPLANTED GLENOID LINER WAS SHARED: WEAR ON THE SURFACE OF THE POLYETHYLENE LINER IS OBSERVED AND IT IS PROVEN THAT THE 4 PEGS BROKE. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - EXACT DATE NOT KNOWN - AND A COUPLE OF PICTURES OF THE EXPLANTED DEVICES HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE PREOP RADIOGRAPHS SHOW AN ANTERO-SUPERIOR ESCAPE OF THE HUMERAL HEAD DUE TO FAILURE OF THE ANTERO-SUPERIOR ROTATOR CUFF. THIS IS ONE OF THE LEADING CAUSES FOR ATSA FAILURE IN THE LITERATURE AND THE REGISTRIES. AS A CONSEQUENCE THE HUMERAL COMPONENT RIDES HIGH ON THE GLENOID IMPLANT WHICH SUBSEQUENTLY LEADS TO EDGE LOAD, INCREASED WEAR AND FINALLY BREAKAGE AND METAL ON METAL CONTACT WITH METALLOSIS. THIS IS A SOMEWHAT UNFAVOURABLE BUT NATURAL COURSE OF ROTATOR CUFF PATHOLOGY AND A FATEFUL COURSE OF EVENTS. THERE IS NO SIGN FOR IMPLANT-RELATED FAILURE". CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #1212787; ACCORDING TO THE MEDICAL CONSULTANT "THE PREOP RADIOGRAPHS SHOW AN ANTERO-SUPERIOR ESCAPE OF THE HUMERAL HEAD DUE TO FAILURE OF THE ANTERO-SUPERIOR ROTATOR CUFF" AND AS A CONSEQUENCE THE HUMERAL COMPONENT RIDES HIGH ON THE GLENOID IMPLANT WHICH SUBSEQUENTLY LEADS TO EDGE LOAD, INCREASED WEAR AND FINALLY BREAKAGE AND METAL ON METAL CONTACT WITH METALLOSIS"; WE CAN STATE THAT THE EVENT WAS PATIENT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF REVISION OF L1 GLENOID LINERS - BELONGING TO THE FAMILY CODES 1377.50.005 + 1377.50.010 + 1377.50.020 + 1377.50.030 - DUE TO DISLOCATION/BREAKAGE 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 MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC TOTAL PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO LOOSENING OF THE LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT #1212787 - STER. 1200337) FROM THE SMR UNCEMENTED GLENOID # SMALL (PRODUCT CODE 1375.20.020, LOT #1412713 - STER. 1400351). IT WAS REPORTED THAT DURING SURGERY THE L1 GLENOID LINER WAS FOUND BROKEN IN THE JOINT, BUT STILL ATTACHED TO THE GLENOID METALBACK. IT IS NOT KNOWN FOR HOW LONG THE IMPLANT WAS LOOSE. ACCORDING TO THE RECEIVED INFORMATION, WEAR ON THE LINER RESULTED IN METALLOSIS. THE FOLLOWING DEVICES GOT EXPLANTED: LINER FOR METALBACK GLENOID SMALL (PRODUCT CODE 1377.50.020, LOT #1212787 - STER. 1200337). SMR HUMERAL HEAD Ø48 MM (PRODUCT CODE 1322.09.480, LOT #1407220 - STER. 1400238). SMR ECCENTRIC ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.274, LOT #1410612 - STER. 1400325). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1414468 - STER. 1500015). THE PROSTHESIS WAS CONVERTED TO REVERSE. THE GLENOID METALBACK WAS LEFT IN SITU AS ITS FIXATION WAS SATISFYING. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2015. PATIENT IS A MALE, 67 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423253 LINER FOR METAL-BACK (UHMWPE) LINER SMALL LINER FOR METAL-BACK (UHMWPE) LINER SMALL PHX LIMACORPORATE S.P.A 377.50.020 1212787

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other