BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LNR SZ23

    MDR report key: 11871612 · Received May 24, 2021

    Report

    Report Number
    0001825034-2021-01577
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    May 3, 2021
    Report Date
    August 24, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BONE QUALITY APPEARS OSTEOPENIC. THE LEFT HIP ACETABULAR IMPLANT ABDUCTION ANGLE IS ELEVATED ABOVE THE RANGE OF NORMAL. A DISLOCATION IS PRESENT AS NOTED BUT AN IMPLANT FRACTURE IS NOT IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 16-104152 490600 RNGLC+ LTD HOLE FIN SHL SZ52. 31-323230 239330 3.2MMX30MM RNGLC+ ACET DRL BIT. 103532 120850 TI LOW PROFILE SCREW 6.5X25MM. 51-100080 3809695 TPRLC 133 FP TYPE1 PPS SO 8.0 . EP-108223 338390 E-POLY 36MM +3 MAXROM LNR SZ23 . 650-1064 753100 CER OPTION TYPE 1 TPR SLEVE -6 . 650-1057 568360 CER BIOLOXD OPTION HD 36MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP ARTHROPLASTY APPROXIMATELY 4.5 YEARS AGO. SUBSEQUENTLY, PATIENT DISLOCATED AND WAS REVISED THREE WEEKS AGO. UPON REVISION WAS DISCOVERED LINER WAS BROKEN. THE HEAD, TAPER SLEEVE AND LINER WERE REMOVED AND REPLACED. 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
    765528 E-POLY 36MM +3 MAXROM LNR SZ23 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 338390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.