BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR ECCENT. GLENOSPHERE Ø 36MM

    MDR report key: 8964770 · Received September 5, 2019

    Report

    Report Number
    3008021110-2019-00097
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 17, 2019
    Report Date
    September 5, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWS
    PMA / PMN Number
    K163397
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR CHECK: BY CHECKING THE STERILIZATION CHARTS OF THE LOT #S INVOLVED, NO ANOMALY WAS FOUND ON A TOTAL OF 40 SMR REV. LINER RETENTIVE +3 MM MANUFACTURED WITH LOT#18AT1W1 STER.1900076; 60 SMR CONNECTOR SMALL R MANUFACTURED WITH LOT#1906308 STER. 1900153; 87 SMR ECCENT. GLENOSPHERE Ø 36MM MANUFACTURED WITH LOT#1812441 STER.1800266. THEREFORE, WE CAN STATE THAT THE COMPONENTS HAVE BEEN REGULARLY STERILIZED BEFORE BEING PLACED ON THE MARKET. EXPLANTS ANALYSIS: EXPLANTED COMPONENTS WERE NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR INVESTIGATION. XRAYS ANALYSIS: WE RECEIVED ONLY ONE X-RAY IMAGE, TAKEN BEFORE THE REVISION SURGERY (EXACT DATE NOT KNOWN). THE IMAGE WAS SENT TO OUR MEDICAL CONSULTANT, WHO COMMENTED: "WITHOUT MORE INFORMATION ON THE PATIENTS HISTORY AND PRE-MORBID RISK FACTORS THERE IS NOT MUCH I CAN SAY OTHER THAN PJI IS A KNOWN COMPLICATION OF ARTHROPLASTY SURGERY OF ANY SORT. THIS FACT SHOULD ALWAYS BE CONSIDERED VERY CAREFULLY IN SURGICAL MANAGEMENT OF SHOULDER DISORDERS." CONCLUSION: WITH THE VERY FEW INFO AVAILABLE ON THIS CASE, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE INFECTION. HOWEVER, BASED ON THE CHECK OF THE STERILIZATION CHARTS (NO DEVIATION DETECTED), THIS EVENT CANNOT BE CLASSIFIED AS PRODUCT RELATED. PMS DATA: ACCORDING TO OUR PMS DATA, SMR REVERSE REVISION RATE DUE TO INFECTION IS VERY LOW: 0.059%. 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 DUE TO RECURRENT INFECTION OCCURRED ON (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2019. DURING REVISION, ONLY THE GLENOSPHERE 1376.09.031 LOT #1812441, THE LINER 1361.50.015 LOT # 18AT1W1 AND THE CONNECTOR 1374.15.305 LOT #1906308 WERE REPLACED. THE PATIENT INVOLVED HAS A CUSTOM MADE IMPLANT (HUMERUS AND GLENOID) THAT WAS NOT REMOVED. ACCORDING TO THE INFO REPORTED, JOINT STABILITY WAS GOOD BEFORE REVISION SURGERY. PATIENT DATA: FEMALE, DOB (B)(6)1955. THE GERM RESPONSIBLE FOR THE INFECTION IS NOT KNOWN. NO OTHER INFO AVAILABLE FOR THIS CASE. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE STERILIZATION CHARTS OF THE LOT #S INVOLVED, NO ANOMALY WAS FOUND ON A TOTAL OF: 87 SMR CONNECTOR SMALL R MANUFACTURED WITH LOT#1906308 STER. 1900153. 60 SMR ECCENT. GLENOSPHERE Ø 36MM MANUFACTURED WITH LOT#1812441 STER.1800266. THEREFORE, WE CAN ENSURE THAT ALL THE COMPONENTS HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO RECURRENT INFECTION OCCURRED ON THE (B)(6) 2019. PREVIOUS SURGERY WAS PERFORMED ON THE (B)(6) 2018. DURING REVISION, ONLY THE GLENOSPHERE 1376.09.031 LOT #1812441, THE LINER (NOT MARKED IN USA) AND THE CONNECTOR 1374.15.305 LOT #1906308 WERE REPLACED. THE PATIENT INVOLVED HAS A CUSTOM MADE IMPLANT (HUMERUS AND GLENOID) THAT WAS NOT REMOVED. ACCORDING TO THE INFO REPORTED, JOINT STABILITY WAS GOOD BEFORE REVISION SURGERY. NO OTHER INFO AVAILABLE FOR THIS CASE. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760245 SMR ECCENT. GLENOSPHERE Ø 36MM SMR ECCENT. GLENOSPHERE Ø 36MM (KWS, KWT, MBF, PHX ) KWS LIMACORPORATE S.P.A. 1376.09.031 1812441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention