BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781173 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01667
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 15, 2008
    Report Date
    April 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PATIENT FACTORS INVOLVING AN UNKNOWN HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED THAT: NO X-RAYS ARE AVAILABLE FOR REVIEW AND NO IMPLANTS WERE RETURNED FOR INVESTIGATION. GIVEN THE FINDINGS OF THIS CASE WITH A COBALT LEVEL ABOVE 80 ¿G/L AND CHROMIUM ABOVE 85 ¿G/L WHILE THRESHOLD VALUES FOR FURTHER INVESTIGATION ARE AROUND 7 ¿G/L, WELL PERFORMING ARTHROPLASTIES DO NOT NORMALLY CAUSE EXCESSIVE METAL IONS TO BE RELEASED. IMPLANT PATHOLOGY MUST BE PRESENT BUT THE NATURE OF THIS IS UNCLEAR. THERE IS NO INFORMATION AVAILABLE REGARDING SUCH POTENTIALLY ADVERSE IMPLANT CONDITIONS AND CONSEQUENTLY IT IS NOT POSSIBLE TO ESTABLISH A ROOT CAUSE OF FAILURE FOR THIS EVENT DUE TO LACK OF ADEQUATE INFORMATION. X-RAYS, MORE CLINICAL AND LABORATORY INFORMATION PLUS RETRIEVAL ANALYSIS ARE THE MOST IMPORTANT TOOLS TO EVALUATE THE PATIENTS CONDITION WITH HIS ARTHROPLASTY. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING RETURN OF DEVICE, OPERATIVE REPORTS, PROGRESS NOTES,MORE CLINICAL AND LABORATORY INFORMATION AND X-RAYS ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE IS AN UNKNOWN HEAD. IT WAS NOTED THAT THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 3, 2014, WE RECEIVED CONFIRMATION THAT THE DEVICE IN QUESTION IS CORMET UNIPOLAR MODULAR HEAD C-TAPER - 4/44MM +8MM OFFSET, CATALOG # 576-04-344, LOT: LAEY. STRYKER ORTHOPAEDICS IS NOT THE MANUFACTURER OF THIS DEVICE AND DOES NOT HAVE THE REPORTING RESPONSIBILITY. THE (B)(4) HAS BEEN NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    "VOLUN (B)(6) 2014 (MW5034918): PT REPORTED THAT ABOUT 6 MONTHS FOLLOWING HIS TOTAL HIP REPLACEMENT SURGERY HE DEVELOPED THE FOLLOWING SYMPTOMS; KIDNEY STONES, KIDNEY INFECTION, UTI, AND FLUID BUILD UP IN HIS HIP. HE STATED THAT HE CONTINUES TO HAVE THESE SYMPTOMS ALONG WITH SEVERE PAIN, DISCOMFORT, SLEEP DISTURBANCES AND EMOTIONAL DISTRESS EVERY 4 TO 6 MONTHS. HE IS CURRENTLY IN THE HOSPITAL DUE TO COMPLICATION WITH HIS KIDNEYS. HE STATED THAT HIS COBALT LEVEL IS ABOVE 80 MCG/L AND CHROMIUM IS ABOVE 85 MCG/L. HE REPORTED THAT HIS DOCTOR PLANS TO START HIM ON DIALYSIS TO RID HIS BLOOD OF METAL AND EVENTUALLY DO A HIP REPLACEMENT.

    Description of Event or Problem · 1

    "VOLUN 14-MAR-2014 (MW5034918): PT REPORTED THAT ABOUT 6 MONTHS FOLLOWING HIS TOTAL HIP REPLACEMENT SURGERY HE DEVELOPED THE FOLLOWING SYMPTOMS; KIDNEY STONES, KIDNEY INFECTION, UTI, AND FLUID BUILD UP IN HIS HIP. HE STATED THAT HE CONTINUES TO HAVE THESE SYMPTOMS ALONG WITH SEVERE PAIN, DISCOMFORT, SLEEP DISTURBANCES AND EMOTIONAL DISTRESS EVERY 4 TO 6 MONTHS. HE IS CURRENTLY IN THE HOSPITAL DUE TO COMPLICATION WITH HIS KIDNEYS. HE STATED THAT HIS COBALT LEVEL IS ABOVE 80 MCG/L AND CHROMIUM IS ABOVE 85 MCG/L. HE REPORTED THAT HIS DOCTOR PLANS TO START HIM ON DIALYSIS TO RID HIS BLOOD OF METAL AND EVENTUALLY DO A HIP REPLACEMENT.

    Description of Event or Problem · 1

    "VOLUN (B)(6) 2014 ((B)(4): PT REPORTED THAT ABOUT 6 MONTHS FOLLOWING HIS TOTAL HIP REPLACEMENT SURGERY HE DEVELOPED THE FOLLOWING SYMPTOMS; KIDNEY STONES, KIDNEY INFECTION, UTI, AND FLUID BUILD UP IN HIS HIP. HE STATED THAT HE CONTINUES TO HAVE THESE SYMPTOMS ALONG WITH SEVERE PAIN, DISCOMFORT, SLEEP DISTURBANCES AND EMOTIONAL DISTRESS EVERY 4 TO 6 MONTHS. HE IS CURRENTLY IN THE HOSPITAL DUE TO COMPLICATION WITH HIS KIDNEYS. HE STATED THAT HIS COBALT LEVEL IS ABOVE 80 MCG/L AND CHROMIUM IS ABOVE 85 MCG/L. HE REPORTED THAT HIS DOCTOR PLANS TO START HIM ON DIALYSIS TO RID HIS BLOOD OF METAL AND EVENTUALLY DO A HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260740 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R