BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1

    MDR report key: 11892378 · Received May 27, 2021

    Report

    Report Number
    3002806535-2021-00233
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 2, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    OQG
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT SUMMARY: AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. THE STERILISATION CERTIFICATES WERE REVIEWED AND CONFIRMED THAT PRODUCT IS STERILISED WITHIN THE SPECIFICATION RANGE. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 3 COMPLAINTS REPORTED WITH THE ITEM (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    HOLD FOR CR 10/16 IT WAS REPORTED THAT A INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED (B)(6) 2021. THREE DAYS POSTOP, THE PATIENT DEVELOPED CELLULITIS ON THE RIGHT HIP.MEDICAL INTERVENTION WAS PROVIDED, AND THE OUTCOME IS PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CONCOMITANT MEDICAL DEVICES: PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET, AS IT REMAINS IMPLANTED. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 54F, CATALOG #: 010000664, LOT #: 6870377; MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 44MM F, CATALOG #: 110024464, LOT #: 080510; MEDICAL PRODUCT: ECHO POR FMRL LAT NC 12X140MM, CATALOG #: 192112, LOT #: 089200. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A INITIAL RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED (B)(6) 2021. THREE DAYS POSTOP, THE PATIENT DEVELOPED CELLULITIS ON THE RIGHT HIP. MEDICAL INTERVENTION WAS PROVIDED, AND THE OUTCOME IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794205 DELTA CER FEM HD 28/0MM T1 BIOLOX DELTA CERAMIC FEM HD OQG BIOMET UK LTD. N/A 3034386

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SEEH10.