BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS

    MDR report key: 17685862 · Received September 5, 2023

    Report

    Report Number
    0002648920-2023-00212
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 13, 2023
    Report Date
    November 10, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWY
    UDI-DI
    00889024633322
    PMA / PMN Number
    K833991
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, H2, H3, H6 VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED LINER WAS RETURNED WITH LOCK RING CORRECTLY ORIENTED IN PLACE. VIEW OF THE RIM FROM THE INNER SPHERICAL SIDE SHOWS DEFORMATION AROUND THE DIAMETER. VIEW OF THE RIM FROM THE OUTER SPHERICAL SIDE SHOWS MULTIPLE LOCATIONS OF INDENTATION DAMAGE TO THE UNDERSIDE OF THE RIM LIP WHERE IT SEATS AGAINST THE SHELL. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE RETURNED DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00811400300 FEMORAL STEM 12/14 NECK TAPER STD. OFFSET SIZE 3 130 MM STEM LENGTH 65762065, 32833305500 CENTRALIZER FOR USE WITH CPT FEMORAL STEMS 65086960, 00801102024 ALLEN MEDULLARY CEMENT PLUGS 1-24 MM DIAMETER FLANGE/12 MM DIAMETER CORE, STORE IN COOL DRY PLACE 65941524, 00500105200 SHELL 52 MM O.D. 64188733, 802202803 FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER +3.5 MM NECK LENGTH 3142865. G2: FOREIGN: SINGAPORE PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BIPOLAR CUP LINER DID NOT BOTTOM OUT PROPERLY INTO THE PATIENT. THE SURGEON REMARKED THAT THE ARTICULATION OF THE BIPOLAR SHELL AND LINER CONSTRUCT AGAINST THE STEM TRUNNION FELT UNUSUAL AND CITED THE BOTTOMING OUT ISSUE. A REPLACEMENT LINER WAS APPLIED USING THE EXISTING SHELL AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560231 LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS PROTHESIS, HIP KWY ZIMMER MANUFACTURING B.V. N/A 65664515 00889024633322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE