BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14

    MDR report key: 16917627 · Received May 12, 2023

    Report

    Report Number
    0009613350-2023-00212
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 21, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430297
    PMA / PMN Number
    K192416
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3, H6, H10. NO PRODUCT WAS RETURNED; THEREFORE VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. VISUAL EXAMINATION OF THE PROVIDED PICTURES REVEALED THAT THE REPORTED BIOLOX HEAD WAS NOT DEPICTED IN ANY OF THE PICTURES. EVALUATION OF THE DEPICTED PRODUCTS IDENTIFIED GOUGES TO THE RIM OF THE DUAL MOBILITY BEARING AND BIO-DEBRIS. GOUGES WERE ALSO NOTED TO THE KINECTIV NECK AND INNER SPHERICAL SURFACE OF THE DUAL MOBILITY LINER. NO FURTHER EVALUATION CAN BE MADE TO THE PROVIDED PICTURES. BASED ON THE INFORMATION AVAILABLE, IT IS NOT KNOWN WHICH PAIRING(S) (HEAD-STEM TAPER, HEAD-POLYETHYLENE LINER, POLYETHYLENE LINER-ACETABULAR LINER, ACETABULAR LINER-SHELL) HAS/HAVE BECOME DETACHED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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: ITEM#:110031013;LOT#:64782999;ITEM NAME:28MM I.D. 46MM O.D. SIZE G BEARING; ITEM#:010000666;LOT#:6972077;ITEM NAME:G7 PPS LTD ACET SHELL 58G; ITEM#:110024465;LOT#:567810 ;ITEM NAME:G7 DUAL MOBILITY LINER 46MM G ; ITEM#:00784804101;LOT#:64516637 ;ITEM NAME:MODULAR NECK X2 12/14 NECK TAPER USE WITH +0 HEADS ONLY; ITEM#:00771301200;LOT#:64960505 ;ITEM NAME: MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 12.5; ITEM#:110031013;LOT#:64782999 ;ITEM NAME:VIVACIT-E DM BEARING 28X46MM; THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT NOTED EXPERIENCING PAIN AND ELEVATED METAL ION LEVELS. IT WAS FOUND THAT THE DUAL MOBILITY BEARING HAD DISASSOCIATED FROM THE HEAD CAUSING THE STEM TO ARTICULATE ON THE DUAL MOBILITY LINER. THE PATIENT ULTIMATELY UNDERWENT A REVISION SURGERY APPROXIMATELY 16 MONTHS POST IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043327 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER SWITZERLAND MANUFACTURER GMBH 00-8775-028-02 3072051 00889024430297

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R SEE H10 NARRATIVE