BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M/H SLD/APX HLE RNGLC SHL 54MM

    MDR report key: 12670959 · Received October 21, 2021

    Report

    Report Number
    3002806535-2021-00457
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    July 2, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868307553
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY SUPPLEMENTAL INFORMATION. COMPLAINT SUMMARY: IT WAS REPORTED, THAT: DURING SURGERY, THE LINER DID NOT FIT THE CUP. A NEW LINER WASN¿T AVAILABLE. A NEW CEMENTED CUP WAS IMPLANTED AFTER THE REMOVAL OF THE UNCEMENTED CUP. PATIENT OUTCOME- PROLONGED SURGERY. A VISUAL INSPECTION OF THE M/H SOLID/APEX HOLE RINGLOC SHELL 54MM ASSEMBLY (ITEM: 11-104054 LOT: 6092384) SHOWS DAMAGE TO THE LOCATION TABS, FRONT FACE, RING LOCATION GROOVE AND INTERNAL SPHERICAL DIM. THE LOCKING RING WHICH IS STILL LOCATED IN THE SHELL IS DAMAGED AND DISTORTED. THIS DEVICE IS USED FOR TREATMENT. THE SHELL AND LINER ARE COMPATIBLE WITH EACH OTHER AS THEY ARE BOTH SZ24. A DIMENSIONAL INSPECTION COULD NOT BE CARRIED OUT DUE TO THE DAMAGE TO THE SHELL MOST LIKELY CAUSED DURING IMPLANTATION OR EXPLANTATION. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. IT HAS BEEN CONFIRMED THAT THE IMPLANT IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO THE REPORTED EVENTS. THE DEFINITIVE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE INVESTIGATION IS COMPLETED BASED ON CURRENTLY AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED. A REVIEW OF THE COMPLAINTS DATABASE SHOWS THAT WE HAVE RECEIVED NO REPORTED EVENTS FOR IMPLANT WOULD NOT ASSEMBLE WITH A MATING IMPLANT FOR THE SAME ITEM NUMBER ¿11-104054¿ PRIOR TO THE REPORTED EVENT. IT WAS CONFIRMED THAT THE REPORTED HARM/HAZARDOUS SITUATION, INCORRECT PRODUCT ASSEMBLY, IS ADDRESSED IN THE ASSOCIATED RISK MANAGEMENT FILE FOR THE REPORTED PRODUCT HOWEVER AS THE FAILURE MODE ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN, A SPECIFIC RISK LINE ITEM CANNOT BE IDENTIFIED. NO CORRECTIVE OR PREVENTIVE ACTION IS REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS DISCOVERED OR RECEIVED THAT MAY ADJUST ANY CONCLUSIONS OR DATA, A SUPPLEMENTAL REPORT WILL BE GENERATED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: DURING SURGERY, THE LINER DID NOT FIT THE CUP. A NEW LINER WAS NOT AVAILABLE. A NEW CEMENTED CUP WAS IMPLANTED AFTER THE REMOVAL OF THE NON-CEMENTED CUP.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN EUROPE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: EPOLY 32MM RLC LNR MROM SZ24, CATALOG NO.: EP-105934, LOT NO.: 490490. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE LINER DID NOT FIT THE CUP. A NEW LINER WAS NOT AVAILABLE. A NEW CEMENTED CUP WAS IMPLANTED AFTER REMOVAL OF THE NON-CEMENTED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575826 M/H SLD/APX HLE RNGLC SHL 54MM MALLORY HEAD PC CUP LZO BIOMET UK LTD. N/A 6092384 00887868307553

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown