BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø50 MM

    MDR report key: 18873366 · Received March 11, 2024

    Report

    Report Number
    3008021110-2024-00020
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 15, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: AFTER THE ACCURATE REVIEW OF THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, WE ESTABLISHED THAT THE SUSPECTED PRODUCT IS THE SMR HUMERAL HEAD Ø50 MM, NOT THE LINER F.MET.BACK GLEN.STANDARD, AS DOCUMENTED IN THE PREVIOUS REPORT. THEREFORE, WITH THIS FOLLOW-UP REPORT, WE ARE UPDATING OUR INVESTIGATION ACCORDINGLY. CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBER INVOLVED, NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT HAS BEEN FOUND OUT. ACCORDING TO THE DATA AVAILABLE, AT LEAST (B)(4) SMR HUMERAL HEADS BELONGING TO THE LOT NUMBER 2208669 AND STERILIZATION NUMBER (B)(6), HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED FOR THIS LOT. NEITHER X-RAYS NOR EXPLANTED COMPONENTS WERE AVAILABLE FOR FURTHER ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE EVENT WAS DUE TO THE PATIENT CONDITION (HOWEVER WE DID NOT RECEIVE ANY OTHER CLINICAL DETAIL REGARDING THE PATIENT). THEREFORE, WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE OCCURRENCE RATE OF REVISION SURGERIES OF SMR HUMERAL HEAD Ø50 MM, BELONGING TO THE FAMILY CODES 1322.09.XXX, DUE TO ROTATOR CUFF FAILURE IS AROUND (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED, NO CORRECTIVE ACTION IS NEEDED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT FURTHER SIMILAR ISSUES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED, NO PRE-EXISTING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE EVENT HAS BEEN FOUND OUT. ACCORDING TO THE DATA AVAILABLE, AT LEAST 17 OUT OF 26 LINERS F.MET.BACK GLEN.STANDARD BELONGING TO THE LOT NUMBER 22AT0LX AND STERILIZATION NUMBER 2200132, HAVE BEEN IMPLANTED, AND THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED FOR THIS LOT. NEITHER X-RAYS NOR EXPLANTED COMPONENTS WERE AVAILABLE FOR FURTHER ANALYSIS. ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE EVENT WAS DUE TO THE PATIENT CONDITION (HOWEVER WE DID NOT RECEIVE ANY OTHER CLINICAL DETAIL REGARDING THE PATIENT). THEREFORE, WE CAN CONCLUDE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE RELEVANT PMS DATA, THE OCCURRENCE RATE OF REVISION SURGERIES OF LINER F.MET.BACK GLEN.STANDARD, BELONGING TO THE FAMILY CODES 1377.50.XXX, DUE TO ROTATOR CUFF FAILURE IS AROUND 0.1%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED, NO CORRECTIVE ACTION IS NEEDED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT FURTHER SIMILAR ISSUES. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6),2024 DUE TO ROTATOR-CUFF FAILURE. THE SMR ANATOMIC IMPLANT, ORIGINALLY IMPLANTED ON (B)(6) 2023, WAS REVISED WITH A SMR REVERSE PROSTHESIS. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: SMR HUMERAL HEAD Ø50 MM (COMMERCIAL CODE 1322.09.500, LOT 2208669, STERILIZATION NUMBER (B)(6)). NEUTRAL ADAPTOR TAPER STANDARD (COMMERCIAL CODE 1330.15.270, LOT 2220567, STERILIZATION NUMBER (B)(6)). SMR FINNED HUMERAL BODY (COMMERCIAL CODE 1350.15.110, LOT 2319417, STERILIZATION NUMBER (B)(6)). LINER F.MET.BACK GLEN.STANDARD (COMMERCIAL CODE 1377.50.010, LOT 22AT0LX, STERILIZATION NUMBER (B)(6)). THEY HAVE BEEN REPLACED WITH THE FOLLOWING NEW COMPONENTS: SMR SHOULDER GLENOSPHERE (COMMERCIAL CODE 1376.09.041, LOT 2330227, STERILIZATION NUMBER (B)(6)) SMR CONNECTOR SMALL + SCREW (COMMERCIAL CODE 1374.15.322, LOT 2310185, STERILIZATION NUMBER (B)(6)). SMR REVERSE HUMERAL BODY (COMMERCIAL CODE 1352.15.010, LOT 2327566, STERILIZATION NUMBER (B)(6)). SMR REVERSE LINER (COMMERCIAL CODE 1365.50.815, LOT 23AT1K7, STERILIZATION NUMBER (B)(6)). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1965. EVENT HAPPENED IN UNITED STATES.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2024 DUE TO ROTATOR-CUFF FAILURE. THE SMR ANATOMIC IMPLANT, ORIGINALLY IMPLANTED ON (B)(6) 2023, WAS REVISED WITH A SMR REVERSE PROSTHESIS. DURING THE REVISION SURGERY THE FOLLOWING COMPONENTS HAVE BEEN EXPLANTED: - SMR HUMERAL HEAD Ø50 MM (COMMERCIAL CODE 1322.09.500, LOT 2208669, STERILIZATION NUMBER 2200148) - NEUTRAL ADAPTOR TAPER STANDARD (COMMERCIAL CODE 1330.15.270, LOT 2220567, STERILIZATION NUMBER 2200318) - SMR FINNED HUMERAL BODY (COMMERCIAL CODE 1350.15.110, LOT 2319417, STERILIZATION NUMBER 2300208) - LINER F.MET.BACK GLEN.STANDARD (COMMERCIAL CODE 1377.50.010, LOT 22AT0LX, STERILIZATION NUMBER 2200132) THEY HAVE BEEN REPLACED WITH THE FOLLOWING NEW COMPONENTS: - SMR SHOULDER GLENOSPHERE (COMMERCIAL CODE 1376.09.041, LOT 2330227, STERILIZATION NUMBER 2400010) - SMR CONNECTOR SMALL + SCREW (COMMERCIAL CODE 1374.15.322, LOT 2310185, STERILIZATION NUMBER 2300124) - SMR REVERSE HUMERAL BODY (COMMERCIAL CODE 1352.15.010, LOT 2327566, STERILIZATION NUMBER 2300282) - SMR REVERSE LINER (COMMERCIAL CODE 1365.50.815, LOT 23AT1K7, STERILIZATION NUMBER 2300195). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1965. EVENT HAPPENED IN UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168429 SMR HUMERAL HEAD Ø50 MM SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A. 1322.09.500 2208669
    581184 SMR HUMERAL HEAD Ø50 MM SMR SHOULDER SYSTEM - HUMERAL HEADS (COCRMO) DIA.50MM KWT LIMACORPORATE S.P.A. 1322.09.500 2208669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention