BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGEN/RNGLC+ LTD 52MM SZ 23

    MDR report key: 9495339 · Received December 19, 2019

    Report

    Report Number
    0001825034-2019-05648
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    August 6, 2018
    Report Date
    May 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K070369
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2018-10671.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: CATALOG#: EP-083650 RLOC-X E1 H/W +3MM 50/36MM 23 LOT#: 3911568 CATALOG#: 650-0554BM TAPERLOC BMPC 11.0X142MM 12/14 LOT#: 3916225 CATALOG#: 650-0837 DELTA CER FM HD 036/0MM 12/14 LOT#: 2016041693.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE OF MFR NUMBER 0001825034-2018-10671.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-05650.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO IMPLANT FRACTURE AND METALLOSIS. 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
    1293279 REGEN/RNGLC+ LTD 52MM SZ 23 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 716290

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R UNK LOCKING RING