BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 36/+2,5

    MDR report key: 3867364 · Received June 11, 2014

    Report

    Report Number
    0002249697-2014-02195
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING PAIN IN THE LEFT HIP AFTER THE REVISION INVOLVING A DELTA V40 HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN WHO CONCLUDED: ¿NO DETERMINATION CAN BE MADE REGARDING THE 'PERSISTENT PELVIC PAIN' IN THIS PATIENT WHICH HAS NOT BEEN SHOWN TO RELATE TO THE TOTAL HIP ARTHROPLASTY COMPONENTS. SHE DOES NOT HAVE A METALLIC HEAD IN EITHER HIP AND HAS SHOWN NO HISTOLOGIC EVIDENCE OF METALLOSIS OR ALTR IN HER LEFT HIP. [¿] THERE IS NO EVIDENCE THAT FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS ARE RESPONSIBLE FOR THIS PATIENT¿S CLINICAL PROBLEMS.¿ DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EXACT CAUSE OF THE REPORTED PAIN COULD NOT BE DETERMINED. A REVIEW OF THE PROVIDED RECORDS BY A CLINICAL CONSULTANT INDICATED THERE IS NO EVIDENCE THE EVENT IS DEVICE RELATED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED PAIN MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE. THE FOLLOWING OTHER DEVICES WERE ADDED TO THIS REPORT: TRIDENT 10° X3 INSERT 36MM ID, CAT# 623-10-36E, LOT# MMJJR9; ACCOLADE PLUS TMZF HIP STEM #2, CAT# 6021-0230, LOT# 9933501; TRIDENT HEMISPHERICAL CLUSTER 52MM, CAT# 502-01-52E, LOT# 10381301; 6.5 CANCELLOUS BONE SCREW 25MM, CAT# 2030-6525-1, LOT# 12964501; 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1, LOT# 22728403; 6.5 CANCELLOUS BONE SCREW 20MM, CAT# 2030-6520-1, LOT# 22108304. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN LEFT STRYKER HIP.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SINCE REVISION SURGERY ON LEFT HIP PATIENT HAS NOT BEEN ABLE TO RETURN TO WORK. PATIENT HAS A LOT OF PAIN AND IS TAKING OXYCODENE WITH OTHER MEDICATIONS TO ALLEVIATE PAIN. PATIENT FEELS VERY SICK. SAYS 2 ROOT CANALS BECAME INFECTED AND FRONT TOOTH FELL OUT. FACE IS DISTORTED LOOKING FROM SORES. PATIENT VERY WEAK AND NAUSEATED. PATIENT SAYS SURGEON SAYS SHE HAS METALLOSIS. PATIENT IS TAKING MEDICATION FOR HIVES. PATIENT IS CONCERNED SURGEON GAVE HER A METAL HEAD AND NOT CERAMIC.

    Description of Event or Problem · 1

    SINCE REVISION SURGERY ON LEFT HIP PATIENT HAS NOT BEEN ABLE TO RETURN TO WORK. PATIENT HAS A LOT OF PAIN AND IS TAKING OXYCODONE WITH OTHER MEDICATIONS TO ALLEVIATE PAIN. PATIENT FEELS VERY SICK. SAYS 2 ROOT CANALS BECAME INFECTED AND FRONT TOOTH FELL OUT. FACE IS DISTORTED LOOKING FROM SORES. PATIENT VERY WEAK AND NAUSEATED. PATIENT SAYS SURGEON SAYS SHE HAS METALLOSIS. PATIENT IS TAKING MEDICATION FOR HIVES. PATIENT IS CONCERNED SURGEON GAVE HER A METAL HEAD AND NOT CERAMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344997 DELTA V-40 CERAMIC HEAD 36/+2,5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 43755901

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention