BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD 46 MM

    MDR report key: 11619686 · Received April 6, 2021

    Report

    Report Number
    3008021110-2021-00026
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    September 9, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF LOT #1114226 - STER. 1200021, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 66 OUT OF (B)(4) HUMERAL HEADS WITH LOT# 1114226 - STER. 1200021 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF LOT #1214162 - STER. 1300077, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, ALL (B)(4) HUMERAL BODIES WITH LOT# 1214162 - STER. 1300077 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. 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: PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; EXPLANTED ITEMS. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, STATING THAT: THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1114226 AND LOT #1214162; ACCORDING TO THE FURTHER INFORMATION REPORTED, PATIENT HAD A FALL WHICH CAUSED TRAUMA AND PAIN; WE CAN CONCLUDE THAT THE EVENT WAS PATIENT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR ANATOMIC HEMI PROSTHESIS DUE TO PAIN 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.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC HEMI PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO PATIENT EXPERIENCING PAIN. IT WAS FURTHER REPORTED BY THE COMPLAINT SOURCE THAT PATIENT HAD A FALL WHICH CAUSED TRAUMA AND THEREFORE PAIN. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE 1322.09.460, LOT# 1114226 - STER. 1200021). SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT# 1214162 - STER. 1300077). THE IMPLANT WAS CONVERTED TO A SMR REVERSE PROSTHESIS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2013. PATIENT IS A MALE, 71 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1114226 AND #1214162, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY OF A HEMI PROSTHESIS PERFORMED ON (B)(6) 2021, DUE TO PATIENT EXPERIENCING PAIN. THE FOLLOWING COMPONENTS WERE EXPLANTED: SMR HUMERAL HEAD Ø46 MM (PRODUCT CODE 1322.09.460, LOT# 1114226 - STER. 1200021). SMR TRAUMA HUMERAL BODY # MEDIUM (PRODUCT CODE 1350.15.010, LOT# 1214162 - STER. 1300077). THE IMPLANT WAS CONVERTED TO REVERSE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2013. PATIENT IS A MALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518689 SMR HUMERAL HEAD 46 MM HUMERAL HEADS (COCRMO) DIA.46MM KWT LIMACORPORATE S.P.A. 1322.09.460 1114226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention