BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10 NARRATIVE

    MDR report key: 6854642 · Received September 11, 2017

    Report

    Report Number
    0001825034-2017-06962
    Event Type
    Injury
    Date Received
    September 11, 2017
    Report Date
    January 22, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK070364
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. AS IT IS UNKNOWN WHICH ACETABULAR LINER WAS IMPLANTED DURING THE INITIAL PROCEDURE, THE DETAILS FOR BOTH DEVICES ARE AS FOLLOWS: DEVICE 1: EPOLY 32 MM RLC LNR MROM SZ25, LOT EP-105935 LOT 900730, EXPIRATION DATE- OCT 31, 2016, (B)(4), DEVICE MFR DATE: OCT 20, 2011, PMA #: K070364. DEVICE 2: E-POLY 40 MM HIWALL LINER, PART EP-107925 E-POLY LOT 777550, EXPIRATION DATE- JAN 31, 2021, (B)(4). DEVICE MFR DATE: JAN 22, 2016, PMA#: K070364.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PT-106062, REGEN/RNGLC+ MULTI 62MM SZ 25, 757720; EP-107925, E-POLY 40MM HIWALL LNR SZ25, 777550; 51-100040, TPRLC 133 FP TYPE1 PPS SO 4.0, 3548465; 650-1056, CER BIOLOXD OPTION HD 32MM, 157660; 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, 428390. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06961, 0001825034-2017-06963.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS BEING REVISED DUE TO UNKNOWN REASONS. 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
    635507 SEE H10 NARRATIVE PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R