BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW Ø6,5 H.25MM

    MDR report key: 12567096 · Received October 4, 2021

    Report

    Report Number
    3008021110-2021-00080
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 17, 2021
    Report Date
    December 31, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THAT THE INVOLVED LOTS #2101048, #2101276 AND #2102140 WERE MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. EXPLANTS ANALYSIS: EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAYS RECEIVED - DATED 26/05/2021 - AND A PICTURE OF EXPLANTED ITEMS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE ORIGINAL POST OPERATIVE FILM SHOWS SEVERAL SURGICAL ERRORS. 1) THE GLENOID BASEPLATE IS TOO HIGH AND IT IS TILTED VERY SLIGHTLY UPWARDS (A BAD MISTAKE). 2) THE INFERIOR SCREW IS TOO SHORT AT 25MM AND IT IS DIRECTED DOWNWARDS AND EVEN THOUGH WITH THE HIGH BASEPLATE IT IS STILL LARGELY MISSING ANY FIXATION IN THE INFERIOR GLENOID. THE HUMERAL COMPONENT IS "OK", BUT THE OSTEOTOMY CUT A BIT LOW AND MAY HAVE COMPROMISED CUFF ATTACHMENT. IN MY HANDS I WOULD MAKE DO WITH ALLOGRAFT BONE AND AXIOMA GLENOID COMPONENT AND WHILE I CANNOT CRITICISE TOO MUCH THE DECISION TO USE A CUSTOM GLENOID, IT IS A LOT MORE EXPENSIVE AND SURGEONS SHOULD ALWAYS BE MINDFUL OF COST!". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2101048, #2101276 AND #2102140; · ACCORDING TO THE MEDICAL EXPERT "THE ORIGINAL POST OPERATIVE FILM SHOWS SEVERAL SURGICAL ERRORS: THE GLENOID BASEPLATE IS TOO HIGH AND IT IS TILTED VERY SLIGHTLY UPWARDS (A BAD MISTAKE)" AND "THE INFERIOR SCREW IS TOO SHORT AT 25MM AND IT IS DIRECTED DOWNWARDS AND EVEN THOUGH WITH THE HIGH BASEPLATE IT IS STILL LARGELY MISSING ANY FIXATION IN THE INFERIOR GLENOID"; · ACCORDING TO THE REPORTED INFORMATION, THE CAUSE OF EARLY LOOSENING OF THE METAL BACK COULD HAVE BEEN THAT THE INFERIOR BONE SCREW WAS NOT SECURE IN BONE DURING PREVIOUS SURGERY DUE TO SUB-OPTIMAL IMPLANT POSITIONING; WE CAN STATE THAT THE EVENT WAS SURGICAL FACTOR RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO LOOSENING OF THE GLENOID COMPONENT 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.

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHR OF THE INVOLVED LOT #2101048, LOT #2101276 AND LOT #2102140 NO PRE-EXISTING ANOMALY WAS FOUND ON THE ITEMS PLACED ON THE MARKET WITH THE SAME LOT #. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6), 2021, DUE TO EARLY LOOSENING OF THE SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2101048 - STER. 2100078) - PRODUCT NOT SOLD IN THE US. IT WAS REPORTED THAT THE CAUSE OF EARLY LOOSENING OF THE METAL BACK COULD HAVE BEEN THAT THE INFERIOR BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2101276 - STER. 2100048) WAS NOT SECURE IN BONE DURING PREVIOUS SURGERY DUE TO SUB-OPTIMAL IMPLANT POSITIONING. NO TRAUMATIC EVENT WAS REPORTED. THE FOLLOWING OTHER COMPONENTS WERE EXPLANTED: · BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2102140 - STER. 2100068). · SMR REVERSE HP LINER LONG (PRODUCT CODE 1365.09.020, LOT #1913992 - STER. 1900367) - PRODUCT NOT SOLD IN THE US. · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2018952 - STER. 2000328). · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2020678 - STER. 2000348) - PRODUCT NOT SOLD IN THE US. THE IMPLANT WAS CONVERTED TO HEMI PROSTHESIS. A CUSTOMIZED GLENOID IMPLANT WAS REQUESTED. PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2021. PATIENT IS A MALE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE IMPLANT PERFORMED ON (B)(6) 2021, DUE TO EARLY LOOSENING OF THE SMR UNCEMENTED GLENOID #SMALL-R (PRODUCT CODE 1375.20.005, LOT #2101048 - STER. 2100078) - PRODUCT NOT SOLD IN THE US. IT WAS REPORTED THAT DURING PREVIOUS SURGERY, THE INFERIOR METAL BACK BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2101276 - STER. 2100048) WAS NOT SECURE IN BONE. THE FOLLOWING COMPONENTS WERE EXPLANTED: BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT #2102140 - STER. 2100068). SMR REVERSE HP LINER LONG (PRODUCT CODE 1365.09.020, LOT #1913992 - STER. 1900367) - PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #2018952 - STER. 2000328) SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2020678 - STER. 2000348) - PRODUCT NOT SOLD IN THE US. THE IMPLANT WAS CONVERTED TO HEMI PROSTHESIS WHILE A CUSTOM METAL BACK IS PRODUCED. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A MALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471174 BONE SCREW Ø6,5 H.25MM BONE SCREWS DIA. 6.5 X H. 25 MM LPH LIMACORPORATE S.P.A. 8420.15.020 2101276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other