BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28F

    MDR report key: 4491824 · Received February 6, 2015

    Report

    Report Number
    0002249697-2015-00265
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 12, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT RELATED TO A STRYKER PRODUCT. NO FURTHER INVESTIGATION REQUIRED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF LABEL USE INVOLVING A TRIDENT 0 DEG CONSTRAINED INSERT 28F WAS REPORTED. CONCLUSIONS: THE REPORTED EVENT IS REGARDING INSTABILITY AFTER REVISION OF A STRYKER AND A COMPETITOR'S CONSTRUCT. A REVIEW OF THE PACKAGING INSERT, Q4357 REV D, INDICATED THE FOLLOWING: DO NOT SUBSTITUTE ANOTHER MANUFACTURER¿S DEVICE FOR ANY COMPONENT OF THE HOWMEDICA OSTEONICS TOTAL HIP SYSTEM. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETAINED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF LABEL USE INVOLVING A TRIDENT 0 DEG CONSTRAINED INSERT 28F WAS REPORTED. CONCLUSIONS: THE REPORTED EVENT IS REGARDING INSTABILITY AFTER REVISION OF A STRYKER AND A COMPETITOR'S CONSTRUCT. A REVIEW OF THE PACKAGING INSERT INDICATED THE FOLLOWING: DO NOT SUBSTITUTE ANOTHER MANUFACTURER¿S DEVICE FOR ANY COMPONENT OF THE HOWMEDICA OSTEONICS TOTAL HIP SYSTEM. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP. FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT. BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THIS EVENT REPORTS A REVISION OF 1ST REVISION IMPLANTS. THE PATIENT HAS BEEN PARALYZED FOR APPROXIMATELY 25 YEARS AND HAD A STANDARD HIP PUT IN AS PRIMARY. THE DOCTOR'S DID NOT THINK IT WOULD HOLD BECAUSE OF THE LACK OF MUSCULATURE, BUT HAD TO TRY A STANDARD HIP FIRST. THE PRIMARY DID NOT HOLD AND A CONSTRAINED HIP WAS IMPLANTED. THE PATIENT DISLOCATED AGAIN AND ANOTHER CONSTRAINED LINER WAS IMPLANTED. THE LATEST HIP HAS BEEN DISLOCATED SINCE THE DAY AFTER HIS 2ND REVISION SURGERY AND HE AND HIS SURGEONS ARE TRYING TO FIND HIP DEVICES THAT WILL HOLD IN HIS HIP WITH HIS CURRENT MEDICAL CONDITIONS. THE PATIENT HAS HAD 3 TOTAL SURGERIES INCLUDING THE PRIMARY AND HIS CURRENT DISLOCATION."

    Description of Event or Problem · 1

    IT WAS REPORTED, "THIS EVENT REPORTS A REVISION OF 1ST REVISION IMPLANTS. THE PATIENT HAS BEEN PARALYZED FOR APPROXIMATELY 25 YEARS AND HAD A STANDARD HIP PUT IN AS PRIMARY. THE DOCTOR'S DID NOT THINK IT WOULD HOLD BECAUSE OF THE LACK OF MUSCULATURE BUT HAD TO TRY A STANDARD HIP FIRST. THE PRIMARY DID NOT HOLD AND A CONSTRAINED HIP WAS IMPLANTED. THE PATIENT DISLOCATED AGAIN AND ANOTHER CONSTRAINED LINER WAS IMPLANTED. THE LATEST HIP HAS BEEN DISLOCATED SINCE THE DAY AFTER HIS 2ND REVISION SURGERY AND HE AND HIS SURGEONS ARE TRYING TO FIND HIP DEVICES THAT WILL HOLD IN HIS HIP WITH HIS CURRENT MEDICAL CONDITIONS. THE PATIENT HAS HAD 3 TOTAL SURGERIES INCLUDING THE PRIMARY AND HIS CURRENT DISLOCATION."

    Description of Event or Problem · 1

    IT WAS REPORTED, "THIS EVENT REPORTS A REVISION OF 1ST REVISION IMPLANTS. THE PATIENT HAS BEEN PARALYZED FOR APPROXIMATELY 25 YEARS AND HAD A STANDARD HIP PUT IN AS PRIMARY. THE DOCTOR'S DID NOT THINK IT WOULD HOLD BECAUSE OF THE LACK OF MUSCULATURE BUT HAD TO TRY A STANDARD HIP FIRST. THE PRIMARY DID NOT HOLD AND A CONSTRAINED HIP WAS IMPLANTED. THE PATIENT DISLOCATED AGAIN AND ANOTHER CONSTRAINED LINER WAS IMPLANTED. THE LATEST HIP HAS BEEN DISLOCATED SINCE THE DAY AFTER HIS 2ND REVISION SURGERY AND HE AND HIS SURGEONS ARE TRYING TO FIND HIP DEVICES THAT WILL HOLD IN HIS HIP WITH HIS CURRENT MEDICAL CONDITIONS. THE PATIENT HAS HAD 3 TOTAL SURGERIES INCLUDING THE PRIMARY AND HIS CURRENT DISLOCATION."

    Description of Event or Problem · 1

    IT WAS REPORTED, "THIS EVENT REPORTS A REVISION OF 1ST REVISION IMPLANTS. THE PATIENT HAS BEEN PARALYZED FOR APPROXIMATELY 25 YEARS AND HAD A STANDARD HIP PUT IN AS PRIMARY. THE DOCTOR'S DID NOT THINK IT WOULD HOLD BECAUSE OF THE LACK OF MUSCULATURE BUT HAD TO TRY A STANDARD HIP FIRST. THE PRIMARY DID NOT HOLD AND A CONSTRAINED HIP WAS IMPLANTED. THE PATIENT DISLOCATED AGAIN AND ANOTHER CONSTRAINED LINER WAS IMPLANTED. THE LATEST HIP HAS BEEN DISLOCATED SINCE THE DAY AFTER HIS 2ND REVISION SURGERY AND HE AND HIS SURGEONS ARE TRYING TO FIND HIP DEVICES THAT WILL HOLD IN HIS HIP WITH HIS CURRENT MEDICAL CONDITIONS. THE PATIENT HAS HAD 3 TOTAL SURGERIES INCLUDING THE PRIMARY AND HIS CURRENT DISLOCATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88917 TRIDENT 0 DEG CONSTRAINED INSERT 28F HIP JOINT METAL/POLYMER CONSTRAINED CEMENTED OR UNCEMENTED PROSTHESIS. KWZ STRYKER ORTHOPAEDICS-MAHWAH MMT68L

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention