BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 12545539 · Received September 29, 2021

    Report

    Report Number
    3002806535-2021-00419
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    March 1, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271175
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. X-RAYS HAVE NOT BEEN PROVIDED. MEDICAL NOTES HAVE BEEN PROVIDED, HOWEVER, NO RECORDS PROVIDED TO REVIEW THAT CORRESPOND WITH THE REPORTED EVENT. THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED (INCLUDING MEDICAL NOTES), A REVIEW OF THE DEVICE HISTORY RECORDS, AND A COMPLAINT HISTORY SEARCH. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM NUMBER AND ONE ADDITIONAL COMPLAINT FOR THE REPORTED ITEM AND LOT COMBINATION. THE ADDITIONAL COMPLAINT FOR THE SAME ITEM/LOT COMBINATION IS FOR AN UNRELATED EVENT. THIS DEVICE IS USED FOR TREATMENT. THE IMPLANTS USED HAVE BEEN CONFIRMED TO BE COMPATIBLE. THESE PART AND LOT COMBINATIONS ARE NOT ASSOCIATED WITH ANY RECALLS AT THE TIME THE SEARCH WAS CONDUCTED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTERMITTENT, SHARP PAIN BELOW THE WAIST TOWARD RIGHT HIP JOINT WHICH IS EXACERBATED BY SITTING. THE PATIENT WAS TREATED WITH MEDICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN EUROPE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: G7 BONEMASTER LTD ACET SHL 58G. CATALOG NO.: 010000706. LOT NO.: 3786916. MEDICAL PRODUCT: G7 HI-WALL E1 LINER 36MM G. CATALOG NO.: 010000937. LOT NO.: 3761000. MEDICAL PRODUCT: TPRLC 133 FP TYPE1 BM HO 13.0. CATALOG NO.: 51-111130. LOT NO.: 3647752. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTERMITTENT, SHARP PAIN BELOW THE WAIST TOWARD RIGHT HIP JOINT WHICH IS EXACERBATED BY SITTING. THE PATIENT WAS TREATED WITH MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446423 DELTA CERAMIC FEM HD 36/0MM BIOLOX DELTA CER FEM HD LG DIA LZO BIOMET UK LTD. N/A 2016050123 00887868271175

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other SEEH10