BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER FOR METAL BACK GLENOID STANDARD

    MDR report key: 13059014 · Received December 22, 2021

    Report

    Report Number
    3008021110-2021-00107
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 9, 2021
    Report Date
    December 16, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K113254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1215370, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 23 ITEMS MANUFACTURED WITH THE SAME LOT #. ACCORDING TO OUR RECORDS, AT LEAST 22 OUT OF 23 LINERS WITH LOT #1215370 - STER. 1300052 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT #1202943 - STER. 1200131, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 31 ITEMS MANUFACTURED WITH THE SAME LOT # - STER. ACCORDING TO OUR RECORDS, AT LEAST 30 OUT OF 31 HUMERAL HEADS WITH LOT #1202943 - STER. 1200131 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. NO MUCH DETAILS ARE 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 COMPONENTS FOR ANALYSIS. PICTURES OF THE EXPLANTED LINER WERE SHARED WITH LIMACORPORATE, CONFIRMING THE PEG OF THE COMPONENT WAS DAMAGED. BASED ON THE FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE AT THIS STAGE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO ANOMALIES ON THE MANUFACTURED COMPONENTS OF THE INVOLVED LOT #S AND THAT THE ITEM WAS ORIGINALLY IMPLANTED IN 2013, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, THE REVISION RATE OF L1 LINERS - BELONGING TO PRODUCT CODES 1377.50.005, 1377.50.010, 1377.50.020, 1377.50.030 - DUE TO DISLOCATION/ BREAKAGE 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 COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR ANATOMIC IMPLANT PERFORMED ON (B)(6) 2021, DUE TO ROTATOR CUFF FAILURE. IT WAS REPORTED THAT THE LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT # 1215370 - STER. 1300052) WAS FOUND TO BE DISLODGED FROM THE BASEPLATE AND WAS FLOATING IN THE JOINT. ACCORDING TO THE COMPLAINT SOURCE THERE WAS SIGNIFICANT SCRATCHING ON THE HUMERAL HEAD FROM ARTICULATING ON THE METAL BACK GLENOID. THE FOLLOWING COMPONENTS WERE EXPLANTED: LINER FOR METAL BACK GLENOID STANDARD (PRODUCT CODE 1377.50.010, LOT #1215370 - STER. 1300052), SMR HUMERAL HEAD Ø44 MM (PRODUCT CODE 1322.09.440, LOT #1202943 - STER. 1200131), NEUTRAL ADAPTOR TAPER STANDARD (PRODUCT CODE 1330.15.270, LOT #1213627 - STER. 1300042), SMR FINNED HUMERAL BODY (PRODUCT CODE 1350.15.110, LOT #1101222 - STER. 1100157), THE PROSTHESIS WAS CONVERTED TO REVERSE. PATIENT IS A MALE, (B)(6). HE HAS A BMI OF 30. ACCORDING TO THE REPORTED INFORMATION, PATIENT'S PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011. THE FIRST REVISION SURGERY TOOK PLACE ON (B)(6) 2013, AND IT WAS DUE TO THE DISSOCIATION OF THE L2 LINER (PRODUCT NOT MARKETED IN THE US). THE REVISION SURGERY WAS REGISTERED AS COMPLAINT # (B)(4). EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964540 LINER FOR METAL BACK GLENOID STANDARD LINER FOR METAL-BACK (UHMWPE) LINER STANDARD KWS LIMACORPORATE S.P.A. 1377.50.010 1215370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other