BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER FOR METAL BACK GLENOID SMALL-R 2

    MDR report key: 10885250 · Received November 23, 2020

    Report

    Report Number
    3008021110-2020-00103
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    October 21, 2020
    Report Date
    March 24, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED (17AT1YS) WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT#. X-RAYS ANALYSIS: X-RAYS (EXACT DATE UNKNOWN) REFERRING TO PRE-OP REVISION SURGERY WERE RECEIVED BY LIMACORPORATE AND EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE TIME INTERVAL BETWEEN THE PRIMARY IMPLANTATION AND THE FIRST REVISION WAS ONLY 4 YEARS WITH A CEMENTED GLENOID. THIS IS UNUSUALLY SHORT AND SUSPICIOUS FOR A NON-IMPLANT-RELATED PROBLEM: INFECTION, ASEPTIC LOOSENING DUE TO IMPLANTATION ERRORS, INSTABILITY. TO CHANGE TO A METALBACK GLENOID WITH PE LINER IS RATHER UNUSUAL, IT COULD HAVE BEEN CEMENTED AGAIN... ANYWAY. THE METAL BACK SHOWS MARKED METAL WEAR WHICH USUALLY IS A MATTER OF SEVERAL WEEKS OR MONTHS TO DEVELOP IN CASES OF INSTABILITY OR LINER DISSOCIATION. THE LINER ITSELF LOOKS RATHER UNREMARKABLE DESPITE THE BROKEN PEG. A SIMPLE DISSOCIATION PROBABLY WOULD RATHER LEAD TO AN INTACT PEG. THE MECHANISM HERE MAY RATHER HAVE BEEN AN INSTABILITY ISSUE THAT LED TO THE SEPARATION OF THE PEG AND SUBSEQUENT WEAR. ONE FACT, THAT POINTS IN THAT DIRECTION IS THE CHANGE TO RSA, PROBABLY DUE TO ROTATOR CUFF FAILURE WHICH MIGHT HAVE BEEN THE REASON FOR THE INSTABILITY THAT LED TO THE SECOND REVISION". EXPLANTS ANALYSIS: EXPLANTS HAVE BEEN RECEIVED BY LIMACORPORATE. VISUAL ANALYSIS WAS PERFORMED. MEDICAL EXPERT'S ANALYSIS WAS JUDGED TO BE EXHAUSTIVE FOR THE ROOT CAUSE ANALYSIS: CASE CAN BE CLASSIFIED AS PATIENT RELATED (ROTATOR CUFF FAILURE --> JOINT INSTABILITY --> SUPERIOR MIGRATION OF THE HUMERUS + POSTERIOR INSTABILITY --> METAL AND METAL CONTACT BETWEEN THE HUMERAL HEAD AND THE SUPERIOR-POSTERIOR QUADRANT OF THE METAL-BACK). PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE ESTIMATED REVISION RATE OF SMR ANATOMIC TOTAL PROSTHESIS DUE TO DISLOCATION IS 0,10%. 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

    SHOULDER REVISION SURGERY PERFORMED ON OCTOBER 21ST, 2020 DUE TO DISLOCATION OF THE LINER SMALL-R (PRODUCT CODE 1377.50.005, LOT 17AT1YS, STER. 1800011). IT WAS REPORTED THAT WHEN THE PATIENT TURNED OVER IN BED, SHE FELT UNUSUAL SOUND IN HER BODY, AND THEN SHE STARTED TO FEEL AS IF METALS TOUCHED EACH OTHER. AT THE TIME OF SURGERY, A PART OF THE GLENOID WAS WORN. THERE WAS NOT MUCH WEAR ON THE LINER AND DURING SURGERY THE LINER'S PEG WAS FOUND ALREADY BROKEN. BLACK DEBRIS WERE FOUND ON BONE AND SOFT TISSUE. OTHER THAN THE LINER, THE FOLLOWING COMPONENTS WERE EXPLANTED: HUMERAL HEAD Ø40MM (PRODUCT CODE 1322.09.400), ECCENTRICAL ADAPTOR TAPER STANDARD + 2MM (PRODUCT CODE 1330.15.272), TRAUMA HUMERAL BODY SHORT WITH LOCKING SCREW (PRODUCT CODE 1350.15.030), METAL BACK GLENOID SMALL-R (PRODUCT CODE 1375.21.005), BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010) AND BONE SCREW Ø6,5 H.20MM (PRODUCT CODE 8420.15.010). THE IMPLANT WAS CONVERTED TO REVERSE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2014 (CEMENTED GLENOID IMPLANTED). 1ST REVISION WAS PERFORMED ON (B)(6) 2018 (CEMENTLESS GLENOID AND LINER IMPLANTED). PATIENT IS A FEMALE, 72 YEARS OLD. THE PATIENT'S ACTIVITY LEVEL IS HIGH. NO INFECTION HISTORY. EVENT HAPPENED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #17AT1YS, NO PRE-EXISTING ANOMALIES WERE DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION OF THE LINER FOR METAL BACK GLENOID SMALL-R (PRODUCT CODE 1377.50.005, LOT# 17AT1YS - STER. 1800011). ACCORDING TO THE COMPLAINT SOURCE, THE HEAD AND THE GLENOID MAY HAVE DIRECTLY INTERFERED AND A PART OF THE GLENOID WAS WORN. BLACK DEBRIS WERE FOUND ON BONE AND SOFT TISSUE. THE FOLLOWING COMPONENTS WERE EXPLANTED: LINER FOR METAL BACK GLENOID SMALL-R (PRODUCT CODE 1377.50.005, LOT# 17AT1YS - STER. 1800011). SMR HUMERAL HEAD 40 MM (PRODUCT CODE 1322.09.400, LOT# 1704602 - STER. 1700304). SMR ECCENTRICAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.272, LOT# 1801634 - STER. 1800096). SMR TRAUMA HUMERAL BODY # SHORT (PRODUCT CODE 1350.15.030, LOT# 1713841 - STER. 1800023). SMR METAL-BACK GLENOID SMALL R (PRODUCT CODE 1375.21.005, LOT# 1713509 - STER. 1700392). BONE SCREW 6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 1800364 - STER. 1800049). BONE SCREW 6,5 H.20MM (PRODUCT CODE 8420.15.010, LOT# 1803029 - STER. 1800093). THE IMPLANT WAS CONVERTED TO REVERSE. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2018. PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349517 LINER FOR METAL BACK GLENOID SMALL-R 2 LINER FOR METAL-BACK (UHMWPE) LINER SMALL-R KWS LIMACORPORATE S.P.A. 1377.50.005 17AT1YS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention