BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CONNECTOR SMALL R

    MDR report key: 8397961 · Received March 7, 2019

    Report

    Report Number
    3008021110-2019-00024
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 26, 2019
    Report Date
    October 1, 2019
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    KWS
    PMA / PMN Number
    K110598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHARTS OF THE LOT #1201703, NO ANOMALY WAS FOUND ON A TOTAL OF 40 CONNECTORS. NO ANOMALY WAS FOUND ON THE ALL COMPONENTS INVOLVED. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT. EXPLANTS ANALYSIS: NO EXPLANTS AVAILABLE TO BE RETURNED TO LIMA CORPORATE FOR FURTHER ANALYSIS. XRAYS ANALYSIS: WE RECEIVED SOME X-RAYS DATED (B)(6) 2015 AND (B)(6) 2019 (PRE-OP REVISION SURGERY) AND SENT THEM TO OUR MEDICAL CONSULTANT FOR A CLINICAL OPINION. HERE WE REPORT HIS COMMENT: "I AGREE THE METAL BACK BASEPLATE WAS A LITTLE HIGH AND SUPERIORLY TILTED AS TO THE CAUSE OF THE LOOSENING. THE PATIENT CONDITION (RHEUMATOID ARTHRITIS) WILL HAVE CONTRIBUTED AT LEAST SOME TO THE FAILURE BUT SUPERIOR INCLINATION IS A BAD MISTAKE." MOREOVER, HE ADDED "RHEUMATOID ARTHRITIS IS ASSOCIATED PARTICULARLY WITH SUPERIOR EROSION SO IT IS AT RISK OF THE GLENOID BEING PLACED INTO THAT INCLINATION, UNLESS THE SURGEON COUNTERACTS THAT BY BONE GRAFTING SUPERIORLY". IT SEEMS THAT PATIENT CONDITION WAS MOSTLY THE CAUSE FOR EROSION OF THE GLENOID BONE AND SURGICAL CHOICE WAS NOT OPTIMAL TO AVOID IT. IN CONCLUSION, ROOT CAUSE OF THIS EVENT WAS THE COMBINATION OF PATIENT CONDITION AND SURGICAL FACTOR (SURGEON RESPONSIBLE FOR THE PREVIOUS SURGERY WAS THE SAME AS THE ONE INVOLVED IN THE REVISION SURGERY). EVENT NOT PRODUCT RELATED. PMS DATA: REVISION RATE WAS EVALUATED BASED ON THE DATA RELATIVE TO L1 METAL BACK GLENOID, WHICH IS THE MAIN COMPONENT INVOLVED IN THIS ISSUE. ACCORDING TO OUR PMS DATA, SPECIFIC REVISION RATE OF L1 METAL BACK GLENOIDS (CODES 1375.20.XXX) DUE TO ASEPTIC LOOSENING IS 0.06%. IN MOST OF THE CASES REPORTED, THE LOOSENING WAS RELATED TO PATIENT'S CONDITION (POOR BONE STOCK/TRAUMA/BONE FRACTURES) AND/OR SURGICAL FACTORS. NO SPECIFIC ACTION FOR THIS CASE, LIMA CORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FUTURE SIMILAR ISSUE.

    Description of Event or Problem · 0

    REVISION SURGERY OF A SMR REVERSE PROSTHESIS DUE TO LOOSENING OCCURRED ON (B)(6) 2019. PRIMARY SURGERY WAS PERFORMED ON THE (B)(6) 2012. DURING THE REVISION SURGERY, METAL BACK GLENOID (NOT MARKED IN USA) AND HUMERAL COMPONENTS (SMR REVERSE HUMERAL BODY - NOT MARKED IN USA; SMR CONNECTOR SMALL R CODE #1374.15.305 LOT #1201703) WERE REMOVED, WHEREAS THE HUMERAL STEM WAS LEFT IN SITU BECAUSE OF GOOD FIXATION. ACCORDING TO THE INFO REPORTED, BOTH THE PATIENT RHEUAMATOID ARTHRITIS AND THE INITIAL SUBOPTIMAL INCLINATION OF THE GLENOID BASEPLATE MAY HAVE CONTRIBUTED TO LOOSENING OF THE GLENOID. SIGNS OF WEAR OF THE POLY GLENOSPHERE AND OF THE SCREW THREADS WERE OBSERVED. EVENT HAPPENED IN (B)(6).

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHARTS OF THE LOT#S INVOLVED (LOT #1202961; LOT #1111683; LOT #1201703), NO ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT#S. WE WILL PROVIDE A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    SHOULDER REVISION SURGERY DUE TO LOOSENING OCCURRED ON (B)(6) 2019. PRIMARY SURGERY TOOK PLACE ON (B)(6) 2012. DURING REVISION, GLENOID (CEMENTLESS GLENOID SMALL-R CODE #1375.25.050 LOT #1202961) AND HUMERAL COMPONENTS (SMR REVERSE HUMERAL BODY CODE #1352.20.010 LOT #1111683; SMR CONNECTOR SMALL R CODE #1374.15.305 LOT #1201703) WERE REMOVED, WHEREAS THE STEM WAS LEFT IN SITU BECAUSE OF THE GOOD FIXATION. TO PROSTHESES LOOSENING MAY HAVE CONTRIBUTED BOTH THE PATIENT RHEUMATOID ARTHRITIS AND THE INITIAL INCLINATION OF THE GLENOID BASEPLATE, WHICH COULD HAVE GENERATED FORCES THAT SHIFTED THE GLENOID UPWARD. SIGNS OF WEAR OF THE GLENOSPHERE AND OF THE SCREW THREADS WERE OBSERVED. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194600 SMR CONNECTOR SMALL R SMR CONNECTOR SMALL R KWS LIMACORPORATE SPA 1374.15.305 1201703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention