BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 2220263 · Received August 16, 2011

    Report

    Report Number
    2648920-2011-00048
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES, X-RAYS OR PHOTOS WERE REC'D; THE CONDITION OF THE COMPONENTS IS UNK, AND IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH CORRECT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE. INCOMPLETE SURGICAL NOTES WERE PROVIDED. PT FACTORS THAT MAY AFFECT PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. DISLOCATION MAY BE CAUSED BY ONE OR MORE OF THE FOLLOWING: MAL-POSITIONING OF THE HIP REPLACEMENT IMPLANTS; NEUROMUSCULAR PROBLEMS OR OTHER MEDICAL CONDITIONS; EXCESSIVE WEIGHT GAIN OR PHYSICAL ACTIVITY; FAILURE TO PRESERVE THE STRENGTH IN THE ABDUCTOR MUSCLES; FAILURE TO RESTORE LEG LENGTH AND / OR PROPER TENSION OF THE TISSUES AROUND THE HIP; POOR QUALITY OF BONE; PRIOR SURGERY OR FRACTURE THROUGH THE HIP JOINT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL HEAD DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LINER WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S RIGHT HIP DISLOCATED. IT IS UNK IF MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL HEAD LPH ZIMMER 60541420

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other UNK ZIMMER ACETABULAR LINER, CATALOG # UNK,| LOT # UNK