BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø46 MM

    MDR report key: 15970188 · Received December 13, 2022

    Report

    Report Number
    3008021110-2022-00128
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 30, 2022
    Report Date
    December 13, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2111772, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 65 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) HUMERAL HEADS WITH LOT #2111772 - STER. 2100240 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 OF REVISION SURGERY. THE X-RAY RECEIVED - DATED (B)(6) 2022 - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THIS IS A COMBINATION OF SURGICAL ERROR AND FATEFUL EVENTS. DISLOCATION IN PRIMARY IS DUE TO SOFT-TISSUE PROBLEMS. THE GLENOID IS SLIGHTLY UPWARD TILTED, THAT MAY HAVE LED TO A SUPERIOR FORCE VECTOR THAT MAY HAVE CONTRIBUTED. THE MISSING PART OF THE ACROMION INDICATES AN INSUFFICIENT ACROMIO-HUMERAL ARCH, WHICH IS A WELL-REPORTED SOURCE FOR ANTERO-SUPERIOR ESCAPE IN SHOULDER ARTHROPLASTY. RSA MAY HAVE BEEN THE BETTER CHOICE FROM THE BEGINNING. THE IMPLANTS ITSELF LOOK UNREMARKABLE. THERE IS NO SIGN OF IMPLANT-RELATED ISSUES HERE". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #2111772; · ACCORDING TO THE MEDICAL EXPERT "THE MISSING PART OF THE ACROMION INDICATES AN INSUFFICIENT ACROMIO-HUMERAL ARCH, WHICH IS A WELL-REPORTED SOURCE FOR ANTERO-SUPERIOR ESCAPE IN SHOULDER ARTHROPLASTY" AND "RSA MAY HAVE BEEN THE BETTER CHOICE FROM THE BEGINNING"; WE CAN STATE THAT THE EVENT WAS BOTH PATIENT-RELATED, AND SURGICAL FACTOR-RELATED. THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR HUMERAL HEADS - (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 PERFORMED ON (B)(6) 2022, DUE TO DISLOCATION OF THE SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE 1322.09.460, LOT #2111772 - STER. 2100240). IT WAS REPORTED THAT PATIENT HAS HAD A PREVIOUS ACROMIOPLASTY BEFORE PRIMARY SURGERY, AND DUE TO THIS THE SURGEON OPTED FOR AN ANATOMIC REPLACEMENT. ACCORDING TO THE RECEIVED INFORMATION, AS PATIENT' SHOULDER DISLOCATED, THE SURGEON THINKS THE HUMERUS MIGRATED SUPERIORLY DUE TO THE MISSING ACROMION. THE FOLLOWING COMPONENTS WERE EXPLANTED, AND THE PROSTHESIS WAS CONVERTED TO REVERSE TO PROVIDE STABILITY: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE 1322.09.460, LOT #2111772 - STER. 2100240). SMR ECCENTRICAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.274, LOT #2206281 - STER. 2200121). SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #2209114 - STER. 2200140). LINER FOR METALBACK GLENOID SMALL-R (PRODUCT CODE 1377.50.005, LOT #22AT0NC - STER. 2200178). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 71 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130024 SMR HUMERAL HEAD Ø46 MM HUMERAL HEADS (COCRMO) DIA.46MM KWT LIMACORPORATE S.P.A. 1322.09.460 2111772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention