BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABG II CUP&CERAMIC INS PK N/HL

    MDR report key: 3002846 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00982
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    November 22, 2012
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING AN ABG CUP AND INSERT WAS REPORTED. THE EVENT WAS CONFIRMED. A VISUAL INSPECTION CONFIRMED THAT THE CERAMIC LINER WAS BROKEN, SIX MEDIUM SIZED FRAGMENTS OF THE INSERT WERE RETURNED. THE HEAD IS NOTED TO BE AN UNKNOWN COMPETITORS PRODUCT. THIS PI CASE HAS NO OBVIOUS CAUSE THAT CAN BE PROVEN WITH THE MATERIAL AVAILABLE. A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. HOWEVER, IT WAS NOTED IN THE REVIEW THAT THE PATIENT APPEARS RATHER OBESE WITH HIS BODY WEIGHT OF (B)(6), ALTHOUGH NO BODY HEIGHT IS PROVIDED TO ALLOW A BMI TO BE CALCULATED. EVEN FOR A TALL PATIENT, THIS BODY WEIGHT WOULD ALREADY REPRESENT SIGNIFICANT OBESITY AND ALTHOUGH OBESITY SHOULD NOT BE CONSIDERED A ROOT CAUSE FOR DEVICE FRACTURE, IT MAY HAVE AGGRAVATED THE EFFECTS OF POTENTIAL OVERLOAD CONDITIONS FROM OTHER ORIGINS THAT ARE SO FAR NOT CLEAR FROM THE AVAILABLE INFORMATION. A REVIEW OF THE IFU INDICATES THAT AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE LOADS ON THE DEVICE THAT CAN LEAD TO FAILURE OF THE FIXATION OF THE DEVICE OR TO FAILURE OF THE DEVICE ITSELF. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE CERAMIC INSERT FRACTURED. THE PROTHEOS STEM (PART NUMBER PI-11-12-17 - CEMENTLESS STEM SIZE 17) WAS CORRECT AND IS STILL IMPLANTED. ONLY THE CEREMIC HEAD AND INSERT WERE REPLACED BY A TRIDENT INSERT AND AND THELIOS HEAD SIZE 32 MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE CERAMIC INSERT FRACTURED. THE PROTHEOS STEM (PART NUMBER PI-11-12-17 - CEMENTLESS STEM SIZE 17) WAS CORRECT AND IS STILL IMPLANTED. ONLY THE CERAMIC HEAD AND INSERT WERE REPLACED BY A TRIDENT INSERT AND THELIOS HEAD SIZE 32 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104783 ABG II CUP&CERAMIC INS PK N/HL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G2951427C

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O| R