BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE FINNED HUMERAL BODY

    MDR report key: 17842219 · Received September 29, 2023

    Report

    Report Number
    3008021110-2023-00112
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 21, 2023
    Report Date
    September 29, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICES. THEREFORE, THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE ACCESSIBLE. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMA CORPORATE PMS DATA, REVISION RATE OF SMR REVERSE IMPLANTS DUE TO INFECTION IS (B)(4). BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMA CORPORATE 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

    REVISION SURGERY ON (B)(6) 2023, DUE TO DEEP INFECTION. IN ONE-STAGE REVISION, THE FOLLOWING COMPONENTS WERE EXPLANTED AND REPLACED: · SMR REVERSE FINNED HUMERAL BODY (PRODUCT CODE 1352.15.050, LOT #1814510 - STER. 1800325) · SMR REVERSE HP LINER LONG (PRODUCT CODE 1362.09.020, LOT #1807120 - STER. 1800201) - PRODUCT NOT SOLD IN THE US · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT #1814875 - STER. 1800328) · SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT #1813606 - STER. 1800299) - PRODUCT NOT SOLD IN THE US. THE BASEPLATE, SCREWS AND STEM WERE LEFT IN SITU. IT WAS REPORTED THAT THE PATHOGEN RESPONSIBLE FOR THE INFECTION IS NOT KNOWN, BUT THERE WAS AN OPEN SINUS LEAKING FLUID. SPECIMEN WERE TAKEN DURING SURGERY FOR ANALYSIS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2018. PATIENT IS A FEMALE, 88 YEARS OLD. EVENT HAPPENED IN NEW ZEALAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353862 SMR REVERSE FINNED HUMERAL BODY FINNED REVERSE HUMERAL BODY FOR TRAUMA PHX LIMACORPORATE S.P.A. 1352.15.050 1814510

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other