BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION (TM) ADM. INSERT

    MDR report key: 3019937 · Received March 25, 2013

    Report

    Report Number
    0002249697-2013-01065
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. A VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS. THE REPORT CONCLUDED: THE FEMORAL HEAD LIKELY DISSOCIATED FROM THE ADM INSERT, RESULTING IN IMPINGEMENT BETWEEN THE FEMORAL STEM AND THE INSERT AND DAMAGES TO THE ARTICULATING SURFACE OF THE FEMORAL HEAD. DEFORMATION DAMAGES ON THE PROXIMAL ARTICULATING SURFACE OF THE ADM INSERT WERE CONSISTENT WITH DAMAGES EXPECTED FROM A DISLOCATION EVENT. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EVALUATED. A REVIEW OF THE CURRENT PACKAGING INSERT, QIN 4400 VERSION D, INDICATED THE FOLLOWING: THE PATIENT¿S WEIGHT. THE HEAVIER THE PATIENT, THE GREATER THE LOAD ON THE PROSTHESIS. AS THE LOADS ON THE PROSTHESIS INCREASE, THE CHANCE A PATIENT WILL SUFFER ADVERSE REACTIONS, SUCH AS FAILURE OF FIFI XATION, LOOSENING, FRACTURE AND DISLOCATION OF THE DEVICE AND CAN LEAD TO A DECREASED SERVICE LIFE. THE EFFECT OF THESE LOADS WILL BE ACCENTUATED WHEN A SMALL SIZED PROSTHESIS IS USED IN LARGER PATIENTS. AS OBESITY IS A CLINICAL DIAGNOSIS, WE LEAVE IT TO THE SURGEON TO MAKE THE DIAGNOSIS BASED ON HIS/HER OWN CLINICAL JUDGMENT. THE PATIENTS BMI IS CALCULATED AS (B)(6) WHICH IS CONSIDERED OBESE. THE EVENT WAS CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE MEDICAL RECORDS WERE NOT PROVIDED. THE MATERIAL ANALYSIS REPORT WAS ABLE TO CONFIRM THAT DISLOCATION LIKELY OCCURRED; HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. MEDICAL RECORDS ARE NEEDED TO FULLY INVESTIGATE THE EVENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND / OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN ADM/MDM 54/48MM POLY HEAD. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN ACCOLADE STEM AND 54MM ADM CUP IMPLANTED YEARS AGO. PATIENT DISLOCATED AND SURGEON FOUND THAT THE STEM AND CUP WERE WELL FIXED, YET THE POLY HEAD WAS STILL IN THE CUP AND THE 28MM HEAD WAS STILL ATTACHED TO THE STEM. IN OTHER WORDS THE TWO HEAD DISASSOCIATED AND THE HIP ITSELF WAS DISLOCATED. PATIENT WAS REVISED WITH A +8MM 28MM METAL HEAD AND NEW ADM POLY HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN ACCOLADE STEM AND 54MM ADM CUP IMPLANTED YEARS AGO. PATIENT DISLOCATED AND SURGEON FOUND THAT THE STEM AND CUP WERE WELL FIXED, YET THE POLY HEAD WAS STILL IN THE CUP AND THE 28MM HEAD WAS STILL ATTACHED TO THE STEM. IN OTHER WORDS THE TWO HEAD DISASSOCIATED AND THE HIP ITSELF WAS DISLOCATED. PATIENT WAS REVISED WITH A +8MM 28MM METAL HEAD AND NEW ADM POLY HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122723 RESTORATION (TM) ADM. INSERT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH G1727166

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R