BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEM HD 40MM TYPE 1 +9MM

    MDR report key: 9311944 · Received November 12, 2019

    Report

    Report Number
    0001825034-2019-05113
    Event Type
    Injury
    Date Received
    November 12, 2019
    Report Date
    March 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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). EP-108525- E-POLY LINER- 181790, 21-109268- HA PAR-5 ACET SHL- 779130, X12-171313- INTEGRAL/X POR RED- 299620, 31-109200- PAR-5 FLANGE PROV SZ SHORT LT- 307940, 109206- PAR-5 FLANGE SZ SHORT NEUTRAL- 299720,, 31-323230-RNGLC+ ACET DRL BIT- 784290, 103532- TI LOW PROFILE SCREW- 678040, 31-323220-RNGLC+ ACET DRL BIT- 031580, 103531- TI LOW PROFILE SCREW- 558060103531- TI LOW PROFILE SCREW- 633300. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05112, 0001825034 - 2019 - 05114, 0001825034 - 2019 - 05115. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAS BEEN INDICATED FOR REVISION DUE TO UNKNOWN REASON; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. 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
    1104452 COCR FEM HD 40MM TYPE 1 +9MM PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 3147102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other