BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT HEMISPHERICAL SOLID BACK SHELL

    MDR report key: 3031980 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01168
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED SEATING/LOCKING ISSUE INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A VISUAL INSPECTION OF THE RETURNED TRIDENT SHELL DID NOT REVEAL ANY ABNORMAL DISCREPANCIES. THERE WAS NO INDICATION THAT THE COATING THICKNESS OF THE RETURNED COMPLAINT UNIT WAS ANY DIFFERENT TO THE IN-PROCESS UNIT. THE ANALYSIS CARRIED OUT INDICATED THE AVERAGE COATING THICKNESS WAS WITHIN SPEC. MEDICAL RECORDS RECEIVED AND EVALUATION PERFORMED; HOWEVER, INFORMATION WAS DEEMED TO BE INSUFFICIENT. ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE RETURNED DEVICE WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING AN EXETER TRIDENT CASE AT (B)(6). THE SURGEON REAMED TO 59, USED A 58 TRIAL CUP (HE PREFERS TO UNDER TRIAL SO AS NOT TO DAMAGE THE FIT OF THE DEFINITIVE), THEN HE REQUESTED A 60 SOLID TRIDENT HEMISPHERICAL CUP TO BE OPENED. WHEN THE IMPLANT WAS HANDED TO THE SURGEON IN THE STERILE FIELD, HE COMMENTED TO THE REP IN THEATRE AT THE TIME, THAT THE SURFACE DIDN'T LOOK OR FEEL AS ROUGH AS IT NORMALLY DID TO HIM. DURING INSERTION, THE CUP DIDN'T GRIP ADEQUATELY TO THE ACETABULUM AND WITHOUT ANY SCREW HOLE OPTIONS HE OPTED NOT TO OPEN A TRITANIUM CLUSTER CUP WHICH HE ENDED UP USING TWO SCREWS WITH, AS THAT CUP TOO DIDN'T HAVE ADEQUATE PURCHASE WITHOUT SCREWS.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING AN EXETER TRIDENT CASE AT (B)(6) HOSPITAL, (B)(6). THE SURGEON REAMED TO 59, USED A 58 TRIAL CUP (HE PREFERS TO UNDER TRIAL SO AS NOT TO DAMAGE THE FIT OF THE DEFINITIVE), THEN HE REQUESTED A 60 SOLID TRIDENT HEMISPHERICAL CUP TO BE OPENED. WHEN THE IMPLANT WAS HANDED TO THE SURGEON IN THE STERILE FIELD, HE COMMENTED TO THE REP IN THEATRE AT THE TIME, THAT THE SURFACE DIDN'T LOOK OR FEEL AS ROUGH AS IT NORMALLY DID TO HIM. DURING INSERTION, THE CUP DIDN'T GRIP ADEQUATELY TO THE ACETABULUM AND WITHOUT ANY SCREW HOLE OPTIONS HE OPTED NOT TO OPEN A TRITANIUM CLUSTER CUP WHICH HE ENDED UP USING TWO SCREWS WITH, AS THAT CUP TOO DIDN'T HAVE ADEQUATE PURCHASE WITHOUT SCREWS.

    Description of Event or Problem · 1

    THE SURGEON WAS DOING AN EXETER TRIDENT CASE AT (B)(6) HOSPITAL, (B)(6). THE SURGEON REAMED TO 59, USED A 58 TRIAL CUP (HE PREFERS TO UNDER TRIAL SO AS NOT TO DAMAGE THE FIT OF THE DEFINITIVE), THEN HE REQUESTED A 60 SOLID TRIDENT HEMISPHERICAL CUP TO BE OPENED. WHEN THE IMPLANT WAS HANDED TO THE SURGEON IN THE STERILE FIELD, HE COMMENTED TO THE REP IN THEATRE AT THE TIME, THAT THE SURFACE DIDN'T LOOK OR FEEL AS ROUGH AS IT NORMALLY DID TO HIM. DURING INSERTION, THE CUP DIDN'T GRIP ADEQUATELY TO THE ACETABULUM AND WITHOUT ANY SCREW HOLE OPTIONS HE OPTED NOT TO OPEN A TRITANIUM CLUSTER CUP WHICH HE ENDED UP USING TWO SCREWS WITH, AS THAT CUP TOO DIDN'T HAVE ADEQUATE PURCHASE WITHOUT SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136853 TRIDENT HEMISPHERICAL SOLID BACK SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 42003001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other