BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM 0MM V40 ALUMINA HEAD

    MDR report key: 4442849 · Received January 22, 2015

    Report

    Report Number
    0002249697-2015-00168
    Event Type
    Injury
    Date Received
    January 22, 2015
    Date of Event
    December 30, 2014
    Report Date
    December 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K003413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING WEAR INVOLVING A CERAMIC WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION NOTED THE ARTICULATING SURFACE CONTAINED AN AREA OF CHIPPING. WEAR INDICATIONS AND METAL TRANSFER MARKINGS WERE OBSERVED AT MULTIPLE AREAS ON THE SURFACE. THE FEMALE TAPER CONTAINED A CONTINUOUS METAL TRANSFER MARKING, AN INDICATION THAT THE TRUNNION WAS LIKELY PROPERLY SEATED IN THE TAPER. THE MATERIAL ANALYSIS REPORT CONCLUDED: THE MATERIAL DAMAGE ON THE INSERT AND THE ARTICULATING SURFACE OF THE HEAD WERE CONSISTENT WITH DAMAGE DUE TO EDGE-LOADING . THE MATERIAL DAMAGE OBSERVED ON THE SLEEVE RIM IS LIKELY DUE TO CONTACT WITH THE STEM NECK. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS FOR CATALOG: 17-2800E THAT INCLUDES LOTS: 4801701, 4117601, 6056301: RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE EXACT CAUSE OF THE FRACTURE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THE MATERIAL DAMAGE ON THE INSERT AND THE ARTICULATING SURFACE OF THE HEAD WERE CONSISTENT WITH DAMAGE DUE TO EDGE-LOADING. THE FEMALE TAPER CONTAINED EVIDENCE OF PROPER SEATING WITH THE TRUNNION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE DEVICE FEATURES EXAMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR HAD A PATIENT COME INTO HIS OFFICE WITH A PAINFUL HIP AND A NOTABLE CLUNK. DR. MADE THE DETERMINATION TO REVISE THE PREVIOUSLY IMPLANTED COMPONENTS AFTER EXAMINATION. THE PATIENT HAD SURGERY TO REPLACE THESE COMPONENTS ON (B)(6) 2014. THE PATIENT WAS REVISED THROUGH AN ANTERIOR LATERAL INCISION. BEFORE REMOVING THE HEAD AND LINER DR. EXCISED GARISH COLORED TISSUE IN AND AROUND THE HIP JOINT. A STRYKER ALUMINA HEAD AND LINER WERE REMOVED FROM THE PATIENT. THE HEAD HAD BLACK AND GRAY MARKINGS ON THE SURFACE. THE LINER HAD SIMILAR BLACK AND GRAY MARKINGS. THE LINER ALSO APPEARED TO BE CHIPPED ON THE RIM WHERE THE ALUMINA CERAMIC AND METAL MET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOCTOR HAD A PATIENT COME INTO HIS OFFICE WITH A PAINFUL HIP AND A NOTABLE CLUNK. DR. MADE THE DETERMINATION TO REVISE THE PREVIOUSLY IMPLANTED COMPONENTS AFTER EXAMINATION. THE PATIENT HAD SURGERY TO REPLACE THESE COMPONENTS ON (B)(6) 2014. THE PATIENT WAS REVISED THROUGH AN ANTERIOR LATERAL INCISION. BEFORE REMOVING THE HEAD AND LINER DR. EXCISED GARISH COLORED TISSUE IN AND AROUND THE HIP JOINT. A STRYKER ALUMINA HEAD AND LINER WERE REMOVED FROM THE PATIENT. THE HEAD HAD BLACK AND GRAY MARKINGS ON THE SURFACE. THE LINER HAD SIMILAR BLACK AND GRAY MARKINGS. THE LINER ALSO APPEARED TO BE CHIPPED ON THE RIM WHERE THE ALUMINA CERAMIC AND METAL MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52342 28MM 0MM V40 ALUMINA HEAD IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention