BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW 6,5 H.30MM

    MDR report key: 9681213 · Received February 7, 2020

    Report

    Report Number
    3008021110-2020-00007
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 22, 2020
    Report Date
    June 30, 2020
    Manufacturer
    LIMA CORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE DHRS OF THE INVOLVED COMPONENTS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE COMPONENTS PLACED ON THE MARKET WITH THE SAME LOT#S (1111161, 1206262, 1204083, 1200133). VERY FEW INFORMATION IS AVAILABLE ON THIS CASE. THE FOLLOWING DETAILS WERE NOT PROVIDED TO US: PRE-REVISION SURGERY XRAYS; PATIENT INFORMATION SUCH AS CLINICAL CONDITION, BMI, ACTIVITY LEVEL; PREVIOUS SURGICAL HISTORY OF THIS PATIENT; PRESENCE OF SYPTOMS SUCH AS PAIN/LOSS OF RANGE OF MOTION. WITHOUT THIS IMPORTANT INFORMATION AND WITHOUT THE POSSIBILITY TO ANALYZE THE EXPLANTS, NO ADDITIONAL ANALYSIS CAN BE PERFORMED AND NO DEFINITIVE CONCLUSION CAN BE DRAWN ON THE CAUSE FOR THE SCAPULAR NOTCHING. THE POLY LINER WEAR AND THE INFERIOR SCREW LOOSENING REPORTED BY THE COMPLAINT SOURCE, MIGTH BE CONSEQUENCES OF THE SCAPULAR NOTCHING. BASED ON THE ANALYSIS OF THE PRODUCTION DOCUMENTS, THE INVOLVED COMPONENTS WERE MANUFACTURED UP TO SPECIFICATIONS, NO DEVIATION DETECTED. THUS, AT THIS STAGE, THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 6 POST-OPERATIVE COMPLAINTS WHERE THE COMPLAINT SOURCE REPORTED SCAPULAR NOTCHING WITH A SMR REVERSE PROSTHESIS. THUS, ON MORE THAN (B)(4) SMR REVERSE PROSTHESIS SOLD WW SINCE 2002, THE SPECIFIC REVISION RATE IS VERY LOW: (B)(4). IN ALL THESE CASES SURGICAL FACTOR OR COMPLICATED PATIENT'S ANATOMY WERE REPORTED AS CONTRIBUTORY FACTORS THAT LED TO THE REVISION. NO SPECIFIC ACTION FOR THIS CASE, LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY OF SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2020. CAUSE FOR REVISION WAS SCAPULAR NOTCHING AND POLY LINER WEAR. ACCORDING TO THE INFORMATION REPORTED, THE BASEPLATE WAS WELL FIXED BUT THE INFERIOR SCREW WAS LOOSE AND NEEDED TO BE REPLACED. THE FOLLOWING COMPONENTS WERE EXPLANTED: 8420.15.030 BONE SCREW Ø6,5 H.30MM LOT#1111161 STER.1100323; 1352.15.050 SMR REVERSE FINNED HUMER. BODY LOT#1206262 STER.1200244; 1360.50.010 SMR REVERSE LINER STANDARD LOT#1204083 STER.1200103 (MODEL NOT MARKETED IN THE USA); 1374.09.105 SMR GLENOSPHERE Ø36MM SMALL-R LOT#1200133 STER.1200050; PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2012. DURING REVISION SURGERY, THE SURGEON IMPLANTED A REVERSE HUMERAL BODY CODE 1352.20.010, A 40MM UMHWPE X-LIMA GLENOSPHERE CODE 1374.50.400, A LONG 40 MM LINER CODE 1365.09.020, A CONNECTOR CODE 1374.15.305 AND A BONE SCREW CODE 8420.15.020. ACCORDING TO THE INFORMATION RECEIVED, THE SURGEON WAS VERY PLEASED WITH THE FINAL OUTCOME. PATIENT DATA: FEMALE, DOB (B)(6) 1943. NO OTHER INFORMATION AVAILABLE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHRS OF THE INVOLVED LOT#S, NO PRE-EXISTING ANOMALY WAS DETECTED. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    REVISION SURGERY OF SMR REVERSE SYSTEM PERFORMED ON (B)(6) 2020. CAUSE FOR REVISION WAS POLY WEAR AND SCAPULAR NOTCHING. ACCORDING TO THE INFORMATION REPORTED, BASE PLATE WAS WELL FIXED BUT INFERIOR SCREW WAS LOOSE AND NEEDED TO BE REPLACED. REVERSE BODY WAS REPLACED AND 36 GLENOSPHERE CHANGED TO A 40. FOLLOWING COMPONENTS WERE EXPLANTED: 8420.15.030 BONE SCREW Ø6,5 H.30MM LOT#1111161 - STER.1100323; 1352.15.050 SMR REVERSE FINNED HUMER. BODY LOT#1206262 - STER.1200244; SMR REVERSE LINER STANDARD - NOT MARKED IN USA; 1374.09.105 SMR GLENOSPHERE Ø36MM SMALL-R LOT#1200133 - STER.1200050. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2012. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143995 BONE SCREW 6,5 H.30MM BONE SCREWS DIA. 6.5 X H. 30 MM (LPH, MBL, LZO, PHX, MBF) LPH LIMA CORPORATE S.P.A. 8420.15.030 1111161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention