BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 8880541 · Received August 9, 2019

    Report

    Report Number
    0001822565-2019-03407
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    November 9, 2017
    Report Date
    January 20, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0002648920-2020-00038.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D11: REF 00-6200-048-22 LOT 62176409 SHELL. REF 00-6250-065-25 LOT 62227303 SCREW. REF 00-6310-048-32 LOT 62202324 LINER. REF 00-7713-007-00 LOT 62207765 M/L STEM. REF 00-7848-013-00 LOT 62163622 TAPER ADAPTER. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0002648920-2020-00038.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED METAL IONS, AND SOFT TISSUE REACTION AS NOTED ON IMAGING. DURING THE REVISION, METALLOSIS WAS NOTED AROUND THE HEAD-NECK INTERFACE. ALL COMPONENTS BUT THE STEM WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN CUP, LOT #: UNKNOWN. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN LINER, LOT #: UNKNOWN. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN M/L TAPER FEMORAL STEM, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019- 03408. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED HAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD AND STEM COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675407 FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62240313

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE