BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLOC-X E1 H/W +3MM 50/36MM 23

    MDR report key: 8932443 · Received August 26, 2019

    Report

    Report Number
    0001825034-2019-03790
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 3002806535.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: UNKNOWN. (B)(4). REPORT SOURCE: (B)(6). THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER 510K NUMBER K023357. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 THAT A LINER COMPONENT FRACTURED. IT IS UNKNOWN WHEN OR HOW THE FRACTURE OCCURRED. NO KNOWN IMPACT OR HARM TO PATIENT IS ASSOCIATED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725149 RLOC-X E1 H/W +3MM 50/36MM 23 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3549268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CUP| UNK HEAD| UNK STEM