BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5

    MDR report key: 7614171 · Received June 19, 2018

    Report

    Report Number
    0002249697-2018-01868
    Event Type
    Injury
    Date Received
    June 19, 2018
    Date of Event
    April 17, 2017
    Report Date
    June 27, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    04546540510778
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING AN ACCOLADE STEM WAS REPORTED. CONCLUSION: BASED ON THE PROVIDED INFORMATION THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. THERE WERE NO ALLEGATIONS MADE AGAINST THE ACCOLADE STEM. THE ACETABULAR SHELL WAS NOTED AS LOOSE IN THE ACETABULUM.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED.

    Description of Event or Problem · 1

    NOTICE RECEIVED FROM PATIENT'S ATTORNEY ALLEGES THAT PATIENT HAD A STRYKER HIP PROSTHESIS WHICH WAS SUBJECT TO STRYKER'S RECALL. IT IS ALLEGED THAT THE PATIENT WOUND UP HAVING MANY OF THE SIGNS AND SYMPTOMS STRYKER SAID THE DEFECTIVE HIP WOULD CAUSE IN ITS RECALL NOTICE AND IN CONSULTATION WITH HIS ORTHOPAEDIC SURGEON HAS HAD A NUMBER OF PROCEDURES TO ADDRESS THE SIGNS AND SYMPTOMS HE WAS DISPLAYING, ULTIMATELY RESULTING IN THE PROSTHESIS BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460028 ACCOLADE (127 DEG) SIZE 5.5 ACCOLADE (127 DEG) SIZE 5.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 18606903 04546540510778

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R