BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID BASEPLATE SMALL-R

    MDR report key: 10783805 · Received November 4, 2020

    Report

    Report Number
    3008021110-2020-00090
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 22, 2020
    Report Date
    September 10, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K133349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BY CHECKING THE DHR OF THE LOT NUMBERS 2011657, 19AQ1NZ AND 20BH003, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THESE LOT NUMBERS. THE COMPONENTS INVOLVED IN THE EVENT HAVE BEEN RETURNED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE INSPECTION DID NOT POINT OUT ANY DEFECT OF THE COMPONENTS, AND THIS SUPPORT THE HYPOTHESIS THAT THE FRACTURE WAS DUE TO A VERY FRAGILE BONE OF THE PATIENT (WHO WAS 83 YEARS OLD AT THE TIME OF THE REVISION SURGERY). ACCORDING TO THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, ALSO THE SURGEON REMARKED THAT THE GLENOID FRACTURE WAS DUE TO POOR BONE QUALITY. WE RECEIVED THE POST-OPERATIVE RADIOGRAPHS, AND WE SENT THEM TO OUR MEDICAL EXPERT, WHO STATED THAT: "THE POSTOP RADIOGRAPHS DO POINT IN THE DIRECTION OF POOR BONE QUALITY, I CAN CONFIRM THAT, ALTHOUGH OSTEOPOROSIS CANNOT BE DIAGNOSED ON RADIOGRAPHS. OTHERWISE THE PATIENT HISTORY IS EXPLANATION ENOUGH: AGE AND GLENOID FRACTURE SEEM TO BE THE MAJOR POINTS. THERE IS NO SIGN OF IMPLANT-RELATED FAILURE." HENCE, CONSIDERING THAT: - NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE EVENT - BASED ON THE INFORMATION RECEIVED BY THE COMPLAINT SOURCE, THE INVESTIGATION PERFORMED INTERNALLY, AND THE MEDICAL EXPERT'S OPINION, THE MOST LIKELY REASON OF THE GLENOID FRACTURE WAS THE POOR BONE QUALITY AND THE AGE OF THE PATIENT. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THE OCCURRENCE RATE OF SMR GLENOID BASEPLATES, BELONGING TO THE PRODUCT CODES 1375.15.605, 1375.15.610, 1375.15.620, DUE TO BONE FRACTURE IS AROUND (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

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2020, IT WAS REPORTED THAT SURGEON WAS REDUCING SHOULDER WITH FINAL IMPLANTS AND NOTICED THAT THE GLENOSPHERE SEEMED LOOSE. GLENOID HAD A FRACTURE WHEN IMPLANTING THE SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2011657), USING THE SMR - GLENOID REAMER S-R/S (PART CODE 9013.75.160, LOT NUMBER 19AQ1NZ) AND THE SMR - REAMER SMALL-R #SHORT (PART CODE 9013.75.351, LOT NUMBER 20BH003). ALL REVERSE IMPLANTS WERE REMOVED: · SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 2011657) · SMR GLENOID PEG TT SMALL-R #S (PART CODE 1375.14.651, LOT NUMBER 2007010) · SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010, LOT NUMBER 2013640) · SMR REVERSE LINER + 3 MM (PART CODE 1360.50.815, LOT NUMBER 20AT0LY) · SMR GLENOSPHERE Ø 36MM (PART CODE 1374.09.111, LOT NUMBER 2004654) · SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 1919129). A HEMI PROSTHESIS WAS IMPLANTED. SURGERY WAS PROLONGED BY 10 MINUTES. PATIENT IS A FEMALE, 83 YEARS OLD. SHE HAD A VAULT WITH OSTEOPOROTIC BONE. EVENT HAPPENED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #: 2011657, #19AQ1NZ, AND #20BH003, 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

    DURING SHOULDER SURGERY PERFORMED ON (B)(6) 2020, IT WAS REPORTED THAT SURGEON WAS REDUCING SHOULDER WITH FINAL IMPLANTS AND NOTICED THAT THE GLENOSPHERE SEEMED LOOSE. GLENOID HAD A FRACTURE WHEN IMPLANTING THE SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE: (B)(4), LOT#: 2011657), USING THE SMR - GLENOID REAMER S-R/S (PRODUCT CODE 9013.75.160, LOT#: 19AQ1NZ) AND THE SMR; REAMER SMALL-R # SHORT (PRODUCT CODE: (B)(4), LOT# 20BH003). ALL REVERSE IMPLANTS WERE REMOVED: SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE: (B)(4), LOT# 2011657); SMR GLENOID PEG TT SMALL-R #S (PRODUCT CODE: (B)(4), LOT# 2007010); SMR REVERSE HUMERAL BODY (PRODUCT CODE: (B)(4), LOT# 2013640); SMR REVERSE LINER + 3 MM (PRODUCT CODE: (B)(4), LOT# 20AT0LY); SMR GLENOSPHERE - 36MM (PRODUCT CODE: (B)(4), LOT# 2004654); SMR SMALL-R CONNECTOR +2 (PRODUCT CODE: (B)(4), LOT# 1919129). A HEMI PROSTHESIS WAS IMPLANTED. SURGERY WAS PROLONGED OF 10 MINUTES. PATIENT IS A FEMALE, (B)(6) YEARS OLD. SHE HAD A VAULT WITH OSTEOPOROTIC BONE. EVENT HAPPENED IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248339 SMR GLENOID BASEPLATE SMALL-R SMR TT METAL BACK BASEPLATE (TI6AL4V) - SMALL R KWS LIMACORPORATE S.P.A. 1375.15.605 2011657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization