BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL LINER 36 MM

    MDR report key: 9494560 · Received December 19, 2019

    Report

    Report Number
    0001822565-2019-05339
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 20, 2019
    Report Date
    May 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: A2; A3; A4; A5; D4; D6; D11; G4; H2; H4; H6. D11: 12-115121 ¿ CERAMIC HEAD ¿ 2911060. 00875705601 ¿ SHELL ¿ 63765514. 00625006520 ¿ BONE SCREW ¿ 63882515. 00625006535 ¿ BONE SCREW ¿ 63729964. 51-101140 ¿ FEMORAL STEM ¿ 3982295. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00875101236- NEUTRAL LINER 36MM-UNKNOWN. 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 THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. ONCE THE INCISION WAS MADE, IT WAS NOTICED THAT THE BIOLOX HEAD WAS CRACKED IN HALF. 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
    1288056 NEUTRAL LINER 36 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 63357587

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R