BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR GLENOID PEG TT SMALL-R #L

    MDR report key: 10626793 · Received October 5, 2020

    Report

    Report Number
    3008021110-2020-00081
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 24, 2020
    Report Date
    February 4, 2022
    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

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1911330, 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) PEGS WITH LOT #1911330 - STER. 1900298 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1702842, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 91 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST (B)(4) SCREWS WITH LOT #1702842 - STER. 1900023 HAVE BEEN IMPLANTED AND NO COMPLAINT HAS BEEN RECEIVED ON THIS LOT #. EXPLANTS ANALYSIS: EXPLANTED ITEMS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. A PICTURE OF THE EXPLANTED TT PEG WAS SHARED: ON THE SURFACE OF THE PEG IT WAS VISIBLE THE MARK GIVEN BY METAL-ON-METAL WEAR WITH THE REVERSE HUMERAL BODY. X-RAYS ANALYSIS: LIMACORPORATE RECEIVED ONE X-RAY REFERRING TO PRE-OPERATIVE REVISION SURGERY. THE X-RAY RECEIVED - TAKEN ONE WEEK BEFORE THE REVISION - HAS BEEN EVALUATED BY A MEDICAL CONSULTANT. FOLLOWING, THE MEDICAL CONSULTANT COMMENTS: "THE XRAY SHOWS COMPLETE FAILURE WITH LOOSENING AND MIGRATION OF THE AXIOMA AND DISLOCATION SO IT IS NOT POSSIBLE TO CONFIRM ABSOLUTELY THAT THE BASEPLATE WAS SUPERIORLY ORIENTED BUT THE SURGEON WILL HAVE ACCESS TO OTHER X RAYS AND DATA THAT WOULD LIKELY CONFIRM THEIR DESCRIPTION OF THE CAUSE OF THE FAILURE. I CAN THEREFORE ONLY AGREE THAT SURGEON ERROR WAS THE CAUSE OF THE FAILURE. WHETHER THE PATIENT FELL OR NOT IS EASY TO DISCOVER. IF THE PATIENT SAYS THEY FELL THEN THAT IS WHAT HAPPENED SO THAT QUESTION SHOULD BE ASKED OF THE PATIENT. IF THE X RAYS PRIOR TO THE IMMEDIATE PRE REVISION SHOW UPWARD (SUPERIOR) TILTING THEN THAT WOULD BE THE MAIN CAUSE OF FAILURE". CONSIDERING THAT: · CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH LOT #1911330 AND #1702842; · ACCORDING TO THE MEDICAL EXPERT "IF THE X RAYS PRIOR TO THE IMMEDIATE PRE REVISION SHOW UPWARD (SUPERIOR) TILTING THEN THAT WOULD BE THE MAIN CAUSE OF FAILURE"; WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF GLENOID PEG TT - BELONGING TO THE FAMILY CODES 1375.14.6XX - DUE TO LOOSENING IS 0.16%. 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 PERFORMED ON (B)(6), 2020, DUE TO LOOSENING OF THE SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT# 1911330 - STER. 1900298). IT WAS REPORTED THAT ON THE PREVIOUS SURGERY THE METAL BACK WAS IMPLANTED TILTED SUPERIORLY. ACCORDING TO THE COMPLAINT SOURCE, THE LOOSENING COULD BE ATTRIBUTED TO SURGEON ERROR AS THE METAL BACK WAS FACING SUPERIORLY. ADDITIONALLY, IT WAS REPORTED THAT SIGNS OF METAL-ON-METAL WEAR WERE VISIBLE: THEY WOULD BE ATTRIBUTED TO THE SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT# 1917285 - STER. 1900396) AND SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT# 1910918 - STER. 1900306) COMING INTO CONTACT WITH THE INFERIOR SCREW, WHICH BROKE, AND THEN IN CONTACT WITH THE TT PEG. IT WAS REPORTED THAT ACCORDING TO THE SURGEON OPERATING THE REVISION SURGERY THE PATIENT POSSIBLY HAD A FALL. THE FOLLOWING IMPLANTS WERE EXPLANTED: · SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT# 1911330 - STER. 1900298). · SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT# 1914048 - STER. 1900380). · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.170, LOT# 1908643 - STER. 1900244). · SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT# 1917285 - STER. 1900396). · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT# 1910918 - STER. 1900306) - PRODUCT NOT MARKETED IN US. · SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1912817 - STER. 1900314). · SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT# 1913719 - STER. 1900305) - PRODUCT NOT MARKETED IN US. · CORTICAL BONE SCREW DIA. 4.5MM - L. 46MM (PRODUCT CODE 8431.15.046, LOT #1702842 - STER. 1900023). · BONE SCREW DIA. 6.5MM - H. 25MM (PRODUCT CODE 8420.15.020, LOT #1911623 - STER. 1900301). A CEMENTED SPACER WAS PLACED IN. PREVIOUS SURGERY PERFORMED ON (B)(6), 2019. PATIENT IS A FEMALE. EVENT HAPPENED IN NEW ZEALAND.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1911330, NO PRE-EXISTING ANOMALY WAS DETECTED ON ALL THE COMPONENTS MANUFACTURED WITH THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF THE TT PEG PERFORMED ON (B)(6) 2020. IT WAS REPORTED THAT THE METAL BACK WAS FACING SUPERIORLY, AND THE LOCKING SCREW OF THE REVERSE HUMERAL BODY WAS FOUND BROKEN. THE SURGEON SUSPECTED THE PATIENT POSSIBLY HAD A FALL. ACCORDING TO THE COMPLAINT SOURCE, SIGNS OF METAL ON METAL WEAR WERE VISIBLE. ACCORDING TO THE COMPLAINT SOURCE, REVERSE LINER AND REVERSE HUMERAL BODY WERE STILL WELL POSITIONED. THE FOLLOWING IMPLANTS WERE EXPLANTED: SMR GLENOID PEG TT SMALL-R #L (PRODUCT CODE 1375.14.653, LOT# 1911330 - STER. 1900298). SMR GLENOID BASEPLATE SMALL-R (PRODUCT CODE 1375.15.605, LOT# 1914048 - STER. 1900380). SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.170, LOT# 1908643 - STER. 1900244). SMR REVERSE HUMERAL BODY SHORT (PRODUCT CODE 1352.15.005, LOT# 1917285 - STER. 1900396). SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1365.09.015, LOT# 1910918 - STER. 1900306) - PRODUCT NOT MARKETED IN US. SMR CONNECTOR SMALL R (PRODUCT CODE 1374.15.305, LOT# 1912817 - STER. 1900314). SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE 1374.50.400, LOT# 1913719 - STER. 1900305) - PRODUCT NOT MARKETED IN US. A CEMENTED SPACER WAS PLACED IN. PREVIOUS SURGERY PERFORMED ON (B)(6) 2019. PATIENT IS A FEMALE. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094423 SMR GLENOID PEG TT SMALL-R #L SMR TT METAL BACK PEG (TI6AL4V) - S-R LONG KWS LIMACORPORATE S.P.A. 1375.14.653 1911330

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention