BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/+3MM T1

    MDR report key: 7647526 · Received June 28, 2018

    Report

    Report Number
    0009610576-2018-00027
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    November 1, 2016
    Report Date
    June 28, 2018
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    LZO
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 110003629, BIOLOX DELTA CER LNR 32MM G, 3181271; 192016, ECHO POR FMRL NC 16X160MM, 890370; 010000667, G7 PPS LTD ACET SHELL 60G. (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. X-RAYS WERE REVIEWED. NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, OR ANY OTHER CONTRIBUTING FACTOR SUCH AS MALALIGNMENT THAT WOULD CAUSE ISSUES WITH ANY OF THE COMPONENTS. NO INDICATIONS OF SUBSIDENCE, POLY WEAR DEBRIS, DISSOCIATION OF IMPLANTS, CORROSION, OSTEOLYSIS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. CONTRIBUTING FACTORS TO THE 1 YEAR PAIN IS THE PREVIOUS REPORTED DISLOCATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT REPORTED EPISODES OF SEVERE PAIN THAT MAY REQUIRE THE USE OF MEDICATION STRONGER THAN AN ASPIRIN DURING THREE MONTHS WHICH DECREASED TO MILD AND MODERATE PAIN DURING ONE YEAR FOLLOW UP VISIT. THE PATIENT ALSO REPORTED A MODERATE LIMP THAT REQUIRED A CANE FOR SUPPORT AND DIFFICULTY WITH DAILY ACTIVITIES DURING THREE MONTH FOLLOW UP VISIT. THE SLIGHT LIMP REPORTED DURING THE ONE YEAR FOLLOW UP VISIT DID NOT REQUIRE ANY SUPPORT. SATISFACTORY RATING OF 9 WAS REPORTED DURING ONE YEAR POST OP VISIT. NO FURTHER INFORMATION WAS PROVIDED AND THE PATIENT'S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490174 DELTA CER FEM HD 32/+3MM T1 PROSTHESIS, HIP LZO BIOMET SPAIN, S.L. N/A 2015110160

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention