BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOSPHERE Ø 36MM

    MDR report key: 16608653 · Received March 24, 2023

    Report

    Report Number
    3008021110-2023-00026
    Event Type
    Injury
    Date Received
    March 24, 2023
    Date of Event
    November 21, 2021
    Report Date
    January 18, 2024
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    MBF
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING MANUFACTURING RECORDS FOR LOT #18AT20T AND 2018949 SHOWED NO PRE-EXISTING ANOMALIES FOUND ON THE COMPONENT MANUFACTURED WITH THESE LOT #'S. WILL SUBMIT FINAL REPORT ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    CHECKING MANUFACTURING RECORDS FOR LOT #18AT20T AND 2018949 SHOWED NO PRE-EXISTING ANOMALIES FOUND ON THE COMPONENTS MANUFACTURED WITH THESE LOT #'S. THE ITEMS INVOLVED WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY NO PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY WERE AVAILABLE. BASED ON THE 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 COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #'S. · PATIENT HAS A HISTORY OF LEFT SHOULDER ROTATOR CUFF ARTHROPATHY. WE CAN SUPPOSE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE PROSTHESIS DUE TO LOOSENING IS 0.09%. 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 ISSUES. NOTE: THIS IS THE FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER SMR REVISION SURGERY PERFORMED ON NOVEMBER 23RD, 2021, DUE TO LOOSENING. PREOPERATIVE DIAGNOSES WAS FAILED REVERSE TOTAL SHOULDER AND POSSIBLE INFECTION. POST OPERATIVE CONFIRMED THE FAILURE "GLENOID COMPONENT WAS LOOSE" BUT SHOWED THAT THERE WAS NO INFECTION. COMPONENTS EXPLANTED: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE #130415140 - LOT #1916281 - STER. #1900429; SMR REVERSE HUMERAL BODY, COMMERCIAL CODE #135215010 - LOT #2019059 - STER. #2000353; SMR REV. LINER RETENTIVE +6 MM, COMMERCIAL CODE #136150820 - LOT #18AT20T - STER. #1900117; SMR GLENOSPHERE Ø 36MM, COMMERCIAL CODE #137409111 - LOT #2018949 - STER. #2000330; SMR SMALL-R CONNECTOR +4, COMMERCIAL CODE #137415314 - LOT #2005275 - STER. #2000200; SMR GLENOID PEG TT SMALL-R #S, COMMERCIAL CODE #137514651 - LOT #2025315 - STER. #2100020; SMR GLENOID BASEPLATE SMALL-R, COMMERCIAL CODE #137515605 - LOT #2021695 - STER. #2100002; PREVIOUS SURGERY - 19-FEB-2021; PATIENT - FEMALE; BIRTH DATE - 07-JUNE-1947; EVENT HAPPENED IN U.S.

    Description of Event or Problem · 0

    DESCRIPTION SHOULDER SMR REVISION SURGERY PERFORMED ON (B)(6) 2021, DUE TO LOOSENING. PREOPERATIVE DIAGNOSES WAS FAILED REVERSE TOTAL SHOULDER AND POSSIBLE INFECTION. POST OPERATIVE CONFIRMED THE FAILURE "GLENOID COMPONENT WAS LOOSE" BUT SHOWED THAT THERE WAS NO INFECTION. SURGEON ELECTED TO USE GLENOID SIDE: ALLOGRAFTED AND THEN RECONSTRUCTED WITH A 3RD PARTY IMPLANTS. COMPONENTS EXPLANTED: SMR CEMENTLESS FINNED STEM, COMMERCIAL CODE #(B)(4) - LOT #1916281 - STER. #(B)(4) SMR REVERSE HUMERAL BODY, COMMERCIAL CODE #(B)(4) - LOT #2019059 - STER. #(B)(4) SMR REV. LINER RETENTIVE +6 MM, COMMERCIAL CODE #(B)(4) - LOT #18AT20T - STER. #(B)(4) SMR GLENOSPHERE Ø 36MM, COMMERCIAL CODE #(B)(4) - LOT #2018949 - STER. #(B)(4) SMR SMALL-R CONNECTOR +4, COMMERCIAL CODE #(B)(4) - LOT #2005275 - STER. #(B)(4) SMR GLENOID PEG TT SMALL-R #S, COMMERCIAL CODE #(B)(4) - LOT #2025315 - STER. #(B)(4) SMR GLENOID BASEPLATE SMALL-R, COMMERCIAL CODE #(B)(4) - LOT #2021695 - STER. #(B)(4) PATIENT MEDICAL HISTORY - PATIENT HAS A HISTORY OF LEFT SHOULDER ROTATOR CUFF ARTHROPATHY. (B(6) 2021 SHOULDER SURGERY DUE TO CUFF FAILURE. (B)(6) 2021, SHOULDER REVISION SURGERY PERFORMED FOR LOOSENING. (OBJECT OF THIS REPORT) (B)(6) 2022, SHOULDER REVISION SURGERY, DUE TO LOOSENING. THIS EVENT WAS REGISTERED AS LIMACORPORATE COMPLAINT 20230069 AND REPORTED TO FDA AS MFR #3008021110-2023-00027. (B)(6) 2022 SURGERY: LEFT SHOULDER EVACUATION OF HEMATOMA AND IRRIGATION AND DEBRIDEMENT FOLLOWED BY WOUND CLOSURE. PATIENT - FEMALE BIRTH DATE - 07-JUNE-1947 EVENT HAPPENED IN U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379396 SMR GLENOSPHERE Ø 36MM SMR GLENOSPHERE Ø 36MM MBF LIMACORPORATE S.P.A 1374.09.111 2018949

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention