BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 40MM +3 HIWALL LNR SZ24

    MDR report key: 7769399 · Received August 9, 2018

    Report

    Report Number
    0001825034-2018-04310
    Event Type
    Injury
    Date Received
    August 9, 2018
    Date of Event
    June 26, 2018
    Report Date
    May 10, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 04310, 0001825034 - 2019 - 02128, 0001825034 - 2019 - 02127. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF PROVIDED PATIENT RADIOGRAPHS CONFIRM THE REPORTED LINER FRACTURE IN-VIVO. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED STEEP POSITIONING OF THE ACETABULAR CUP WITH ACETABULAR INCLINATION ANGLE MEASURING APPROXIMATE 70°. THERE IS ASYMMETRIC POSITIONING OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP, CONSISTENT WITH POLYETHYLENE WEAR. HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LINER FRACTURE IN-VIVO. X-RAY REVIEW IDENTIFIED HETEROTOPIC OSSIFICATION AND MALPOSITIONING OF THE ACETABULAR CUP AS WELL ECCENTRIC LOADING OF THE FEMORAL HEAD INDICATIVE OF POLY WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: LOT NUMBER ¿ 793640; EXPIRATION DATE ¿ MAY 31, 2017; DEVICE MANUFACTURE DATE - MAY 1, 2012; OR LOT NUMBER ¿ 344320; EXPIRATION DATE ¿ AUG 31, 2016; DEVICE MANUFACTURE DATE - AUG 1, 2011. CONCOMITANT MEDICAL PRODUCTS: 103532, TI LOW PROFILE SCREW 6.5X25MM, 170910; 103533, TI LOW PROFILE SCREW 6.5X30MM, 182860; 13-104156, M/H 3HOLE RLC SHL NRS 56MM/L24, 411970; EP-108524, E-POLY 40MM +3 HIWALL LNR SZ24, 793640; 192409, ECHO POR FMRL RED NC 9X125MM, 644330; S001140, SELEX/MAGNUM MOD HD 40MM STD, 389200; 103532, TI LOW PROFILE SCREW 6.5X25MM, 765860; 103533, TI LOW PROFILE SCREW 6.5X30MM, 440310; 13-104156, M/H 3HOLE RLC SHL NRS 56MM/L24, 450590; EP-108524, E-POLY 40MM +3 HIWALL LNR SZ24, 344320; 192409, ECHO POR FMRL RED NC 9X125MM, 730540; S331140, SELEX/MAGNUM MOD HD 40MM +3, 499300. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LINER FRACTURE IN-VIVO. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608211 E-POLY 40MM +3 HIWALL LNR SZ24 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R