BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR HUMERAL HEAD Ø42 MM

    MDR report key: 10578740 · Received September 24, 2020

    Report

    Report Number
    3008021110-2020-00071
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    August 25, 2020
    Report Date
    December 28, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWT
    PMA / PMN Number
    K100858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1801769, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) HUMERAL HEADS WITH LOT# 1801769 - STER. 1800088 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1713729, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) ADAPTORS WITH LOT# 1713729 - STER. 1800027 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1815003, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF (B)(4) MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) HUMERAL BODIES WITH LOT# 1815003 - STER. 1800340 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. EXPLANTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, HOWEVER IT WAS NOT AVAILABLE: · PRE-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY; · PICTURES OF EXPLANTED COMPONENTS; · ADDITIONAL CLINICAL DATA FOR THE PATIENT. 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 MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOTS #1801769, #1713729 AND #1815003, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR ANATOMIC HEMI IMPLANTS 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

    CONVERSION OF A SMR ANATOMIC HEMI IMPLANT TO A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6), 2020, DUE TO PAIN. ACCORDING TO THE COMPLAINT SOURCE, PATIENT HAD ON-GOING PAIN AFTER PREVIOUS SURGERY. IT WAS REPORTED THAT THE CAUSE OF PAIN WAS NOT KNOWN. ACCORDING TO THE REPORTED INFORMATION, THERE WAS A QUERY FOR INFECTION, HOWEVER NO POSITIVE CULTURES WERE FOUND. THE FOLLOWING COMPONENTS WERE EXPLANTED: · SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT# 1801769 - STER. 1800088) · SMR CTA HEADS ADAPTOR Ø36 MM (PRODUCT CODE 1352.15.200, LOT# 1713729 - STER. 1800027) · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT# 1815003 - STER. 1800340) A CUSTOMIZED GLENOID IMPLANT WAS PLACED IN. ACCORDING TO THE COMPLAINT SOURCE, THE CUSTOMIZED COMPONENT WAS REQUESTED AS THE GLENOID WAS FRACTURED AT THE TIME OF THE PREVIOUS ARTHROPLASTY PERFORMED ON (B)(6), 2019. AT THAT TIME, THE GLENOID FRACTURE WAS FIXED AND THE SMR ANATOMIC HEMI WAS IMPLANTED. THE PATIENT IS A FEMALE, 80 YEARS OLD. IT WAS REPORTED THAT HER BMI IS NORMAL. EVENT HAPPENED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1801769, #1713729 AND #1815003 NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THESE LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT NUMBERS. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    CONVERSION SURGERY TO SMR REVERSE PROSTHESIS DUE TO PAIN PERFORMED ON (B)(6) 2020. PATIENT HAD ON-GOING PAIN AND, ACCORDING TO THE COMPLAINT SOURCE, THE CAUSE OF PAIN IS NOT KNOWN. THERE WAS A QUERY FOR INFECTION BUT NO POSITIVE CULTURES. DURING THE CONVERSION, THE FOLLOWING COMPONENTS: SMR HUMERAL HEAD Ø42 MM (PRODUCT CODE 1322.09.420, LOT# 1801769, STER. 1800088), SMR CTA HEADS ADAPTOR Ø36 MM (PRODUCT CODE 1352.15.200, LOT# 1713729, STER. 1800027), SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT# 1815003 - STER. 1800340). WERE EXPLANTED AND REVERSE HP LINER + REVERSE HUMERAL BODY + REVERSE HP GLENOSPHERE + A CONNECTOR WITH SCREW AND A CUSTOMIZED GLENOID WERE IMPLANTED. ACCORDING TO THE INFO REPORTED, A CUSTOMIZED GLENOID WAS CHOSEN BECAUSE THE GLENOID WAS PREVIOUSLY FRACTURED AT THE TIME OF THE HEMIARTHROPLASTY. DURING THE PREVIOUS SURGERY, PERFORMED ON (B)(6) 2019, THE GLENOID FRACTURE WAS FIXED AND THE HEMI IMPLANTED. THE PATIENT IS A FEMALE, NORMAL BMI, (B)(6). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047345 SMR HUMERAL HEAD Ø42 MM HUMERAL HEADS (COCRMO) DIA.42MM KWT LIMACORPORATE S.P.A. 1322.09.420 1801769

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention