BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 2

    MDR report key: 12093546 · Received June 30, 2021

    Report

    Report Number
    0001822565-2021-01791
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 16, 2021
    Report Date
    November 22, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K182048
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.   VISUAL REVIEW OF THE DEVICE SHOWS ITEM AND LOT ETCH ON THE TAPER TOP SURFACE. SCRATCH TO THE COATED SURFACE ON THE UNDERSIDE OF THE STEM COLLAR. NO OTHER DAMAGE WAS NOTED. PRINT SHOWS VISUAL PRODUCT IDENTIFIERS FOR COLLAR AND NECK RELIEF FEATURES ON THE STEM. THESE WERE PRESENT ON THIS DEVICE. PRODUCT IDENTIFIER FOR STEM LENGTH OF 121 +/-1 WAS MEASURED TO VERIFY PART IDENTITY AND WAS CORRECT LENGTH. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS TO WHY THE STEM WOULD NOT SEAT FULLY, A REVIEW OF THE PRODUCT SIZE (OVERALL LENGTH) WAS MEASURED AND FOUND TO BE CONFORMING. 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: ITEM NUMBER 110010263 ITEM NAME G7 OSSEOTI MULTIHOLE 50MMD L 50MM D LOT # 65005557. ITEM NUMBER 00625006530 ITEM NAME BONE SCREW SELF-TAPPING6.5 MM DIA. 30 MM LENGTH LOT# J6960420. ITEM NUMBER 00625006520 ITEM NAME BONE SCREW SELF-TAPPING6.5 MM DIA. 20 MM LENGTH LOT # 64700661. ITEM NUMBER 30103604 ITEM NAME LINER NEUTRAL 36 MM I.D. SIZE D FOR USE WITH G7 ACETABULAR SYSTEM ONLY LOT # 65052128. ITEM NUMBER 00877503601 ITEM NAME BIOLOX® DELTA, CERAMICFEMORAL HEAD, S, ø 36/-3.5, TAPER 12/14 LOT # 3063405. ITEM NUMBER 31-323230 ITEM NAME 3.2MMX30MM RNGLC+ ACETDRL BIT LOT # 762660. ITEM NUMBER 574101020 ITEM NAME AVENIR CMPL HA STD NC SIZE 2 LOT # 3053817. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. AS THE LOCATION IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT THA, THE STEM WOULD NOT SEAT. ANOTHER STEM WAS USED TO COMPLETE THE SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. 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
    990403 FEMORAL STEM CEMENTLESS COLLARED STANDARD OFFSET 12/14 TAPER SIZE 2 PROSTHETIC, HIP LZO ZIMMER BIOMET, INC. N/A 3040912

    Patients

    Seq Age Sex Outcome Treatment
    1 Female