BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 23

    MDR report key: 8821557 · Received July 24, 2019

    Report

    Report Number
    3002806535-2019-00619
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    April 28, 2015
    Report Date
    August 10, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    00880304202337
    PMA / PMN Number
    K926107
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON DUE TO AVASCULAR HIP NECROSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: BIHAPRO SHELL HA/PC 52MM LN 23, CATALOG #: 165743, LOT #: 1170828, MEDICAL PRODUCT: BIHAPRO MK III HA/PC SZ6 LH T1, CATALOG #: 12-164566, LOT #: 124027, MEDICAL PRODUCT: BIHAPRO FEM PMMA CNTRLZR 13MM, CATALOG #: 164204, LOT #: 1343577, MEDICAL PRODUCT: DELTA CERAMIC FEM HD 028/ 0MM, CATALOG #: 164136, LOT #: 1673301. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00564, 3002806535-2019- 00618, 3002806535-2019-00617, 3002806535-2019-00620. REPORT SOURCE: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT SURGERY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON DUE TO AVASCULAR HIP NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616315 ARCOM 28MM RNGLOC LNR HWALL 23 HIP PROSTHESIS LPH BIOMET UK LTD. N/A 2009020675 00880304202337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention