BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMR FINNED HUMERAL BODY

    MDR report key: 8801508 · Received July 18, 2019

    Report

    Report Number
    3008021110-2019-00081
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 5, 2019
    Report Date
    November 11, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHART OF THE INVOLVED LOT#S, NO ANOMALY WAS FOUND ON A TOTAL OF (B)(4) HUMERAL BODIES MANUFACTURED WITH LOT #0900677 ON A TOTAL OF (B)(4) STEMS MANUFACTURED STEMS MANUFACTURED WITH LOT #0901688 THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. EXPLANTS WERE REQUESTED FOR ANALYSIS, BUT THEY WERE NOT RETURNED TO US AS PER HOSPITAL POLICY. PICTURES OF THE EXPLANTS SHOW RELEVANT BONE GROWTH ON THE HUMERAL BODY, WHICH COULD HAVE LEAD TO ISSUE IN REMOVING THE COMPONENT. AT THIS STAGE, WE ARE NOT ABLE TO INVESTIGATE THE ROOT CASE OF THE EVENT. STATING THAT: NO ANOMALY WAS DETECTED BY THE CHECK OF THE MANUFACTURING CHART WE ARE NOT AWARE OF ANY FURTHER ISSUE RELATED TO THESE COMPONENTS WE CAN CONCLUDE THAT THIS EVENT IS NOT PRODUCT RELATED. SHOULD WE RECEIVE FURTHER INFORMATION, WE WILL SUBMIT A FOLLOW-UP REPORT. PMS DATA: ACCORDING TO OUR PMS DATA, THIS IS THE ONLY CASE OF BONE FRACTURE DUE TO ENGAGEMENT BETWEEN THE STEM AND THE HUMERAL BODY ON MORE THAN (B)(4). NO CORRECTIVE ACTION IMPLEMENTED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL KEEP THE MARKET MONITORED.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2019 DURING SMR REVISION SURGERY. ACCORDING TO THE INFORMATION REPORTED, THE SURGEON WAS REMOVING THE HUMERAL BODY CODE 1350.15.110 LOT #0900677 FROM THE STEM CODE 1304.15.180 LOT #0901688, WHEN THE TUBEROSITIES GOT FRACTURED. IT IS REPORTED THAT THE STEM AND THE HUMERAL BODY WERE FUSED TOGETHER DUE TO BONE TISSUE IN THEIR JUNCTION. THIS COULD HAVE CONTRIBUTED TO CAUSE THE INTRA-OP BONE FRACTURE. THE STEM AND THE HUMERAL BODY WERE IMPLANTED ON (B)(6) 2009. THE FRACTURE DID NOT PROLONG THE SURGERY VERY LONG BECAUSE THE TUBEROSITIES WERE ONLY PARTIALLY FRACTURED AND THE SURGEON WAS SATISFIED THAT THEY WERE STILL IN A GOOD POSITION TO HEAL. EVENT OCCURRED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHART OF THE INVOLVED LOT#S, NO ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL REPORT ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2019 DURING SMR REVISION SURGERY (COMPLAINT # (B)(4)). ACCORDING TO THE INFO REPORTED, THE SURGEON WAS REMOVING THE HUMERAL BODY CODE 1350.15.110 LOT #0900677 FROM THE STEM CODE 1304.15.180 LOT #0901688, WHEN THE TUBEROSITIES GOT FRACTURED. IT IS REPORTED THAT THE STEM AND THE HUMERAL BODY WERE FUSED TOGETHER DUE TO BONE TISSUE IN THEIR JUNCTION. THIS COULD HAVE CONTRIBUTED TO CAUSE THE INTRA-OP BONE FRACTURE. THE FRACTURE DID NOT PROLONG THE SURGERY VERY LONG BECAUSE THE TUBEROSITIES WERE ONLY PARTIALLY FRACTURED AND THE SURGEON WAS SATISFIED THAT THEY WERE STILL IN A GOOD POSITION TO HEAL. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595559 SMR FINNED HUMERAL BODY SMR FINNED HUMERAL BODY HSD LIMACORPORATE SPA 1350.15.110 0900677

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization