BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 16909586 · Received May 11, 2023

    Report

    Report Number
    3008021110-2023-00050
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    May 4, 2023
    Report Date
    September 4, 2023
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2016929, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 63 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 61 OUT OF 63 HUMERAL BODIES WITH LOT #2016929 - STER. 2000330 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. DEVICE ANALYSIS THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS LIMACORPORATE RECEIVED A TOTAL OF TWO X-RAYS REFERRING TO PRE-OPERATIVE OF THE REVISION SURGERY. THE X-RAYS RECEIVED - DATED 07/10/2021 - AND A PICTURE OF THE EXPLANTS HAVE BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "I CANNOT REALLY DETERMINE THE REASON FOR DISASSEMBLY. THE PROVIDED PRE-OP RADIOGRAPHS SHOW A LOT OF IRREGULAR BONE CHANGES AT THE HUMERUS AND THE SCAPULA, SOME SUTURE ANCHOR REMNANTS POSTERIORLY IN THE SOFT TISSUES, ALL PROBABLY DUE TO PREVIOUS OPERATIONS. WHETHER THE SURGEON HAD PROBLEMS TO ASSEMBLE IT PROPERLY IN THE FIRST INSTANCE DUE TO PATIENT RELATED ANATOMIC PROBLEMS OR WHETHER HE DID IT IMPROPERLY ARE BEYOND MY KNOWLEDGE. THE EXPLANTS LOOK UNREMARKABLE. I CANNOT SEE ANY IMPLANT RELATED ISSUES HERE". CONSIDERING THAT: CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE COMPONENTS MANUFACTURED WITH LOT #2016929; ACCORDING TO THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY, THE REASON FOR THE DISASSEMBLY ISN'T KNOWN, BUT THE HYPOTHESIS IS THAT THE TAPER BETWEEN THE HUMERAL BODY AND THE HUMERAL STEM DIDN'T ENGAGE AT TIME OF THE IMPLANT; ACCORDING TO THE MEDICAL EXPERT "I CANNOT REALLY DETERMINE THE REASON FOR DISASSEMBLY. [...] WHETHER THE SURGEON HAD PROBLEMS TO ASSEMBLE IT PROPERLY IN THE FIRST INSTANCE DUE TO PATIENT RELATED ANATOMIC PROBLEMS OR WHETHER HE DID IT IMPROPERLY ARE BEYOND MY KNOWLEDGE" AND "THE EXPLANTS LOOK UNREMARKABLE. I CANNOT SEE ANY IMPLANT RELATED ISSUES HERE"; WE CANNOT DEFINE THE ROOT CAUSE OF THE REVISION SURGERY. STILL, BASED ON THE ABOVE EVIDENCE WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO POST-OPERATIVE DISASSEMBLY OF THE HUMERAL BODY FROM THE HUMERAL STEM 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. LIMACORPORATE CONTINUES MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2016929, NO PRE-EXISTING ANOMALIES WERE FOUND ON THE (B)(4) COMPONENTS MANUFACTURED WITH THAT LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THE LOT #. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO DISASSEMBLY OF THE COMPONENTS. IT WAS REPORTED THAT THE SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330) WAS NOT ENGAGED, BECAME LOOSE AND WAS SPINNING ON THE HUMERAL STEM, WHICH WAS WELL FIXED. ACCORDING TO THE RECEIVED INFORMATION, THE SURGEON WAS NOT SURE ON THE REASON FOR THE DISASSEMBLY, HYPOTHESIZING THAT THE TAPER BETWEEN THE HUMERAL BODY AND THE HUMERAL STEM DIDN'T ENGAGE. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330). SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2022505 - STER. 2100038) - PRODUCT NOT SOLD IN THE US. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. DURING IT, LIMA'S GLENOID COMPONENTS AND REVERSE HUMERAL BODY AND REVERSE LINER WERE IMPLANTED. PATIENT IS A MALE. NO TRAUMATIC EVENT WAS REPORTED. NO OTHER INFORMATION WAS AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2023 DUE TO DISASSEMBLY OF THE COMPONENTS. IT WAS REPORTED THAT THE SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330) WAS NOT ENGAGED. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2016929 - STER. 2000330). · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT #2022505 - STER. 2100038) - PRODUCT NOT SOLD IN THE US PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. PATIENT IS A MALE. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864208 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) PHX LIMACORPORATE S.P.A. 1352.15.005 2016929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other