BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL

    MDR report key: 17128660 · Received June 14, 2023

    Report

    Report Number
    0001822565-2023-01627
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    May 19, 2023
    Report Date
    August 17, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024149816
    PMA / PMN Number
    K093846
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SUBSEQUENT TO THIS, REVISION WAS PERFORMED. THERE IS A DISLOCATION OF THE RIGHT HIP ARTHROPLASTY. EXTENSIVE RADIOLUCENCY ALONG THE PROXIMAL FEMORAL STEM IS PRESENT AS NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 11-301353 ARCOS CON SZ C HI 80MM 590390. 00223200204 INTEGRAL SHORT GTR W/ 2 CABLES 56705650. 00625006550 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH 64084511. 00625006550 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH J7307819. 00875705802 58MM O.D. SIZE LL POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH LL LINERS 63290514. 31-323240 3.2MMX40MM RNGLC+ ACET DRL BIT 233750. 31-323260 3.2MMX60MM RNGLC+ ACET DRL BIT 597010. 650-0662 DELTA CERAMIC FEM HD 36/+3MM 3062848. 310.250S DRILL BIT 2.5MM, L 110/85MM 2-FLUTE, F/QUICK COUPLING 9L85899 DEPUY. G2: FOREIGN: AUSTRALIA MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 01338. 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.

    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 THE PATIENT WAS IMPLANTED WITH NON- ZIMMER BIOMET PRODUCTS. THE NON-ZIMMER BIOMET PRODUCTS WERE REVISED FOR AN UNKNOWN REASON, AND THE PATIENT WAS IMPLANTED WITH THE ARCOS STEM. THE ARCOS STEM WAS UNDERSIZED DUE TO AN IATROGENIC ERROR ON THE SURGEON¿S BEHALF DURING THE FIRST REVISION (NON-ZB TO ZB PRODUCTS). THE PATIENT WAS REVISED DUE TO THE STEM UNDER SIZING AND DISLOCATION THAT OCCURRED DUE TO THE STEM UNDER SIZING. THERE WAS NO NEED TO ADJUST THE ACETABULAR SIDE AS IT REMAINED STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1875162 36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL PROTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 64239463 00889024149816

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R SEE H10 NARRATIVE