BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28F

    MDR report key: 2925409 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00130
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. FURTHERMORE, A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6276-7-015, LOT # CAXMC03D, DESCRIPTION: MOD CON DIST STEM 15 X 155 MM. CAT # 6276-1-023, LOT # 40276805, DESCRIPTION: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL (B)(4). CAT # 6570-0-228, LOT # 40689701, DESCRIPTION: DELTA V-40 CERAMIC HEAD 28/+4. CAT # 509-02-58F, LOT # MLKM51, DESCRIPTION: TRITANIUM REVISION ACETABULAR. CAT # 2080-0040, LOT # MJLJ2H, DESCRIPTION: GAP PLATE SCREWS. CAT # 2080-0035, LOT # , MLKN97 AND MLKE35. DESCRIPTION: GAP PLATE SCREWS. CAT # 2080-0015, LOT # MLMM51, DESCRIPTION: GAP PLATE SCREWS. CAT # 2060-0000-1, LOT # MLMRHD, DESCRIPTION: ACETABULAR DOME HOLE PLUG. CAT # 6704-0-520, LOT # 40366507, DESCRIPTION: D-M 2.0MM BEADED CABLE SET VIT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. (B)(4): NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ALTR REVISION RIGHT HIP DONE (B)(6) 2012. PATIENT'S HIP BECAME INFECTED. DOCTOR EXPLANTED HIP AND IMPLANTED SPACERS. DOCTOR SAID THERE WAS MASSIVE CONTINUED SOFT TISSUE NECROSIS. DOCTOR SAID ADDITIONAL REVISION WILL BE DONE WHEN INFECTION CLEARS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ALTR REVISION RIGHT HIP DONE (B)(6) 2012. PATIENT'S HIP BECAME INFECTED. DOCTOR EXPLANTED HIP AND IMPLANTED SPACERS. DOCTOR SAID THERE WAS MASSIVE CONTINUED SOFT TISSUE NECROSIS. DOCTOR SAID ADDITIONAL REVISION WILL BE DONE WHEN INFECTION CLEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30362 TRIDENT 0 DEG CONSTRAINED INSERT 28F IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MKK4Y9

    Patients

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