BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR REVERSE HUMERAL BODY SHORT

    MDR report key: 16182303 · Received January 17, 2023

    Report

    Report Number
    3008021110-2023-00002
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    January 10, 2023
    Report Date
    April 28, 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 #2204936, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 40 OUT OF 58 REVERSE HUMERAL BODIES WITH LOT #2204936 - STER. 2200106 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #2216978, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) REVERSE HP LINERS WITH LOT #2216978 - STER. 2200226 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. IT WAS REPORTED THAT DURING THE PREVIOUS SURGERY THE CHOSEN STANDARD REVERSE BODY WAS INTRAOPERATIVELY CHANGED TO A SHORT REVERSE BODY AFTER THE STEM HAD BEEN CEMENTED IN. ACCORDING TO THE SURGICAL TECHNIQUE, THE FINAL HUMERAL BODY IS ASSEMBLED ON THE HUMERAL STEM ON THE BACK TABLE. THE ASSEMBLY IS THEN PLACED IN THE HUMERAL CANAL THAT HAD PREVIOUSLY BEEN PREPARED, AND IT IS TAPPED. THEREFORE, THE OBSERVED LOOSENING OF THE REVERSE HUMERAL BODY COULD BE EXPLAINED BY THE SUB-OPTIMAL SURGICAL TECHNIQUE AND BY THE EVENTUAL PRESENCE OF BONE AMONG THE TAPERS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: · HISTORY OF PATIENT SHOULDER SURGERIES · X-RAYS RELATED TO THE REVISION SURGERY; BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #2204936 AND #2216978; · IT WAS REPORTED THAT THE CAUSE OF THE DISLOCATION MIGHT HAVE BEEN IMPINGEMENT AND THE LOOSE REVERSE HUMERAL BODY; · ACCORDING TO THE REPORTED INFORMATION, DURING THE PREVIOUS SURGERY THE SHORT REVERSE BODY WAS IMPLANTED ON THE HUMERAL STEM AFTER IT HAD BEEN CEMENTED IN; WE CAN STATE THAT THE EVENT WAS SURGICAL FACTOR RELATED. THE EVENT IS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO DISLOCATION 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 WILL CONTINUE 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 LOTS#: 2204936 AND #: 2216978, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED THE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THOSE LOTS#. WE SUBMIT A FINAL MDR WHEN THE INVESTIGATION GETS COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2023, DUE TO DISLOCATION. ACCORDING TO THE RECEIVED INFORMATION THERE WAS IMPINGEMENT, AND THE REVERSE BODY WAS LOOSE EVENTUALLY CAUSING THE DISLOCATION. IT WAS REPORTED THAT DURING THE PREVIOUS SURGERY THE CHOSEN STANDARD REVERSE BODY WAS INTRAOPERATIVELY CHANGED TO A SHORT REVERSE BODY AFTER THE STEM HAD BEEN CEMENTED IN, AND THIS MIGHT HAVE POSSIBLY CONTRIBUTED TO THE LOOSENING OF THE DEVICE. INDEED, THE DEVICE WAS NOT IMPACTED ONTO THE STEM ON THE BACK TABLE, AND IT IS SUPPOSED THAT SOME BONE GOT IN THE WAY AND CAUSED THE TAPER NOT TO CONNECT PROPERLY. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT #2204936 - STER. 2200106) · SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2216978 - STER. 2200226) - PRODUCT NOT SOLD IN THE US · SMR SMALL-R CONNECTOR +4 (PRODUCT CODE 1374.15.314, LOT #2213445 - STER. 2200195) · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2222431 - STER. 2200268) - PRODUCT NOT SOLD IN THE US ADDITIONAL BONE WAS CLEARED DURING THE REVISION SURGERY TO MAKE SURE THE TAPER WAS ENGAGED BETWEEN THE HUMERAL STEM AND THE NEW SHORT REVERSE HUMERAL BODY IMPLANTED. IT WAS REPORTED THAT THE CENTER OF ROTATION HAD BEEN RAISED. A 36MM GLENOSPHERE, +4 CONNECTOR AND A 36 +3 RETENTIVE LINER TO IMPROVE THE STABILITY WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE. IT WAS REPORTED HE HAS AN AVERAGE BMI. 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 DISLOCATION. ACCORDING TO THE RECEIVED INFORMATION THERE WAS IMPINGEMENT, AND THE REVERSE BODY WAS LOOSE EVENTUALLY CAUSING THE DISLOCATION. IT WAS REPORTED THAT DURING THE PREVIOUS SURGERY THE CHOSEN STANDARD REVERSE BODY WAS INTRAOPERATIVELY CHANGED TO A SHORT REVERSE BODY AFTER THE STEM HAD BEEN CEMENTED IN, AND THIS MIGHT HAVE POSSIBLY CONTRIBUTED TO THE LOOSENING OF THE DEVICE (IT IS SUPPOSED THAT SOME BONE GOT IN THE WAY AND CAUSED THE TAPER NOT TO CONNECT PROPERLY). THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE: 1352.15.005, LOT#: 2204936, STER. 2200106). SMR REVERSE HP LINER SHORT (PRODUCT CODE: 1365.09.010, LOT#: 2216978, STER. 2200226) PRODUCT NOT SOLD IN THE US. SMR SMALL-R CONNECTOR +4 (PRODUCT CODE: 1374.15.314, LOT#: 2213445, STER. 2200195). SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE: 1374.50.400, LOT#: 2222431, STER. 2200268) PRODUCT NOT SOLD IN THE US. ADDITIONAL BONE WAS CLEARED DURING THE REVISION SURGERY TO MAKE SURE THE TAPER WAS ENGAGED BETWEEN STEM AND THE NEW SHORT REVERSE BODY IMPLANTED. IT WAS REPORTED THAT THE CENTER OF ROTATION HAS BEEN RAISED. A 36MM GLENOSPHERE, +4 CONNECTOR AND A 36 +3 RETENTIVE LINER WERE PLACED IN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A MALE. IT WAS REPORTED HE HAS AN AVERAGE BMI. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225422 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) PHX LIMACORPORATE S.P.A. 1352.15.005 2204936
    1818003 SMR REVERSE HUMERAL BODY SHORT SHORT REVERSE HUMERAL BODY (INVERSION ONLY) PHX LIMACORPORATE S.P.A. 1352.15.005 2204936

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention