BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVACIT-E DM BEARING 28X44MM

    MDR report key: 17669506 · Received September 1, 2023

    Report

    Report Number
    0001822565-2023-02371
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 27, 2023
    Report Date
    October 3, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024572706
    PMA / PMN Number
    K190656
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 110024464, LOT# 949240, G7 DUAL MOBILITY LINER 44MM F; CAT# 11-301300, LOT# 65788746, ARCOS CON SZ A STD 50MM; CAT# 00-6250-065-30, LOT# J7421000, BONE SCREW 6.5X30 SELFTAP; CAT# 11-300814, LOT# 65938420, ARCOS 14X150MM SPL TPR DIST; CAT# 110010246, LOT# 65616938, G7 OSSEOTI 4 HOLE SHELL 56MM F; CAT# 650-1055, LOT# 3114832, CER BIOLOXD OPTION HD 28MM; CAT# 650-1066, LOT# 3050938, CER OPT TYPE 1 TPR SLEVE0MM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H6. THE FOLLOWING SECTION WAS CORRECTED: H4. NO PRODUCT WAS RETURNED; HOWEVER, A PICTURE WAS RETURNED AND EVALUATED. A VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THAT THE CERAMIC HEAD AND BEARING WERE EXPLANTED AND WERE COVERED IN BIO-DEBRIS. SOME SCRATCHING WAS NOTED TO THE OUTER SPHERICAL SURFACE OF THE BEARING. NO FURTHER EVALUATION CAN BE MADE FROM THE PROVIDED PICTURE. MEDICAL RECORDS WERE NOT PROVIDED. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE PROVIDED PICTURE. 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

    IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A 28MM HEAD DISASSOCIATION FROM A 44MM BEARING THAT WAS IMPLANTED. THE PATIENT HAD ABDUCTOR INSUFFICIENCY AND DISLOCATED. IT IS BELIEVED THAT THE HEAD DISASSOCIATED FROM THE DUAL WHEN THE EVENT HAPPENED, OR WHEN AN ATTEMPT WAS MADE TO RELOCATE IT. IT WAS NOTED THAT SURGICAL TECHNIQUE WAS UTILIZED, AND THE DUAL WAS ASSEMBLED PROPERLY DURING THE ORIGINAL SURGERY. THE PATIENT WAS CONVERTED TO A CONSTRAINED PRODUCT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183864 VIVACIT-E DM BEARING 28X44MM PROTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 65781071 00889024572706

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R