BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTL. REV. STEM Ø15 MM

    MDR report key: 12826682 · Received November 17, 2021

    Report

    Report Number
    3008021110-2021-00090
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    August 11, 2021
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K113523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS CHECK: THE PRODUCTION DOCUMENTS OF THE INVOLVED STEM (SMR CEMENTL. REV. STEM Ø15 MM CODE 1308.15.154 LOT 1702303 STER. 1800030) WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS DETECTED: THE DEVICES OF THIS LOT NUMBER WERE RELEASED ON THE MARKET COMPLIANT TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT NUMBER (1702303). X-RAYS ANALYSIS: THE AVAILABLE X-RAYS AND THE PICTURES OF THE EXPLANTED COMPONENT WERE SENT TO OUR MEDICAL CONSULTANT FOR A CLINICAL EVALUATION. THREE RADIOGRAPHIC IMAGES WERE AVAILABLE: TWO POST-OPERATIVE X-RAYS OF THE PREVIOUS SURGERY, DATED (B)(6) 2018 AND ONE ADDITIONAL IMAGE WITH UNKNOWN DATE. THE MEDICAL CONSULTANT'S COMMENTS WERE THE FOLLOWING: "XRAY 1 [POST-OPERATIVE OF PREVIOUS SURGERY] ALREADY SHOWS OSTEOLYSIS ALL AROUND THE STEM, SO IT LOOKS VERY SUSPICIOUS OF INFECTION TO ME. ADDITIONALLY, THE METAPHYSIS SHOWS A BONE DEFECT, WHICH LIMITS THE CAPACITY TO RESIST TORSIONAL FORCES AT THE HUMERAL IMPLANT-BONE INTERFACE. THE EXPLANTS LOOK UNREMARKABLE. IN MY OPINION THERE IS NO SIGN OF IMPLANT FAILURE HERE, THE FAILURE IS ATTRIBUTED TO INFECTION OR SURGICAL OR PATIENT RELATED ISSUES." RETRIEVED COMPONENT ANALYSIS: THE EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR A SPECIFIC ANALYSIS, THUS NO FURTHER INVESTIGATION IS POSSIBLE. CONCLUSION AND PMS DATA: BASED ON THE AVAILABLE INFORMATION, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE REVISION SURGERY REPORTED, HOWEVER: - THE ABSENCE OF PRE-EXISTING ANOMALIES DETECTED BY THE CHECK OF THE PRODUCTION DOCUMENTS OF THE LOT INVOLVED CONFIRMED THAT THE INCOLVED HUMERAL STEM HAD BEEN MANUFACTURED UP TO SPECIFICATIONS, - OUR MEDICAL CONSULTANT SUGGESTED THAT CONTRIBUTORY FACTORS MIGHT BE SURGICAL OR PATIENT-RELATED OR POSSIBLE INFECTION (THE PRESENCE OF INFECTION WAS HOWEVER NEVER REPORTED BY THE COMPLAINT SOURCE), THEREFORE, THIS EVENT DOES NOT SEEM TO BE PRODUCT-RELATED. BASED ON LIMACORPORATE PMS DATA, WE ESTIMATE A REVISION RATE OF THE SMR CEMENTLESS REVISION STEMS (PRODUCT CODES 1308.15.134 TO 1308.15.166) DUE TO STEM LOOSENING/SUBSIDENCE OF (B)(4). NO CORRECTIVE ACTION IS NEEDED FOLLOWING THIS SPECIFIC COMPLAINT. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THE PRODUCTION DOCUMENTS OF THE INVOLVED STEM (SMR CEMENTL. REV. STEM Ø15 MM CODE 1308.15.154 LOT 1702303 STER. 1800030) WERE CHECKED AND NO PRE-EXISTING ANOMALY WAS DETECTED: THE DEVICES OF THIS LOT NUMBER WERE RELEASED ON THE MARKET COMPLIANT TO SPECIFICATIONS. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE SAME LOT NUMBER (1702303). A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATIONS.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF SMR REVERSE DUE TO STEM LOOSENING WHICH CAUSED DISTAL HUMERAL PAIN FROM WINDSCREEN WIPER EFFECT. THE REVISION SURGERY TOOK PLACE ON (B)(6), 2021, THE PREVIOUS SURGERY ON (B)(6) 2018. DURING THE REVISION SURGERY A CUSTOM-MADE STEM WAS IMPLANTED. PATIENT IS FEMALE, 57 YEARS OLD, WITH A BMI OF 35 KG/M2, SEDENTARY. THIS INCIDENT OCCURRED IN GREAT BRITAIN.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF SMR REVERSE DUE TO STEM LOOSENING WHICH CAUSED DISTAL HUMERAL PAIN FROM WINDSCREEN WIPER EFFECT. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2021, THE PREVIOUS SURGERY ON (B)(6) 2018. DURING THE REVISION SURGERY A CUSTOM-MADE STEM WAS IMPLANTED. PATIENT IS FEMALE, (B)(6) YEARS OLD, WITH A BMI OF 35 KG/M2, SEDENTARY. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731130 SMR CEMENTL. REV. STEM Ø15 MM UNCEMENTED REVISION STEMS (TI6AL4V) DIA.15MM, H.150MM KWS LIMACORPORATE SPA 1308.15.154 1702303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention