BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITRAX V40 SLEEVE +4MM

    MDR report key: 6177408 · Received December 15, 2016

    Report

    Report Number
    0002249697-2016-03929
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    August 22, 2006
    Report Date
    March 14, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K954077
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LIMB LENGTH DISCREPANCY INVOLVING AN RELIANCE STEM WAS REPORTED. FOLLOWING A CLINICIAN REVIEW LIMB LENGTH DISCREPANCY WAS NOT CONFIRMED BUT MALPOSITION WAS CONFIRMED. CONCLUSION: THE EVENT REPORTED LIMB LENGTH DISCREPANCY INVOLVING A RELIANCE STEM, THERE IS NO INDICATION THAT THE UNITRAX SLEEVE REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER CALLED STRYKER ENDOSCOPY ON (B)(6) 2016 TO ASK FOR INFORMATION REGARDING AN IMPLANT IN HER HIP (REFERRED TO AS "RADIANCE" ON THE CALL). CALL WAS RETURNED ON (B)(6) 2016 AT 11:05AM PDT. CUSTOMER REPORTED THAT THE SURGERY WAS ON (B)(6) 2006. PATIENT FELL ON VACATION IN AND REQUIRED SURGERY. PATIENT SAID THAT DUE TO THE SMALL SIZE OF THE HOSPITAL, THEY DIDN'T HAVE THE CORRECT SIZE OF IMPLANT AND HAD TO IMPLANT A SMALLER SIZE THAN SHE REQUIRED AND HER HIP IS NOW LOWER THAN THE OTHER HIP. SHE HAS RECENTLY STARTED TO EXPERIENCE PAIN IN HER HIP AND GOING DOWN HER LEG. PATIENT WAS TOLD THIS PRODUCT WAS RECALLED IN 2006 AND IS REQUESTING INFORMATION ON THE RECALL SO SHE CAN TAKE THAT TO HER DOCTOR. PATIENT STATED IMPLANT CARD STATES STRYKER HIP AND THE PROCEDURE DATE BUT DOES NOT HAVE THE PART NUMBER OF THE PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER CALLED STRYKER ENDOSCOPY ON 8/1/2016 TO ASK FOR INFORMATION REGARDING AN IMPLANT IN HER HIP (REFERRED TO AS "RADIANCE" ON THE CALL). CALL WAS RETURNED ON 8/2/2016 AT 11:05AM PDT. CUSTOMER REPORTED THAT THE SURGERY WAS ON (B)(6) 2006. PATIENT FELL ON VACATION IN AND REQUIRED SURGERY. PATIENT SAID THAT DUE TO THE SMALL SIZE OF THE HOSPITAL, THEY DIDN'T HAVE THE CORRECT SIZE OF IMPLANT AND HAD TO IMPLANT A SMALLER SIZE THAN SHE REQUIRED AND HER HIP IS NOW LOWER THAN THE OTHER HIP. SHE HAS RECENTLY STARTED TO EXPERIENCE PAIN IN HER HIP AND GOING DOWN HER LEG. PATIENT WAS TOLD THIS PRODUCT WAS RECALLED IN 2006 AND IS REQUESTING INFORMATION ON THE RECALL SO SHE CAN TAKE THAT TO HER DOCTOR. PATIENT STATED IMPLANT CARD STATES STRYKER HIP AND THE PROCEDURE DATE BUT DOES NOT HAVE THE PART NUMBER OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829662 UNITRAX V40 SLEEVE +4MM HIP JOINT FEMORAL (HEMI-HIP) METALLIC CEMENTED OR UNCEMENTED PROSTHESIS KWL STRYKER ORTHOPAEDICS-MAHWAH 11294901

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other