BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH

    MDR report key: 15878179 · Received November 29, 2022

    Report

    Report Number
    0002648920-2022-00237
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    November 1, 2022
    Report Date
    February 23, 2023
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024119840
    PMA / PMN Number
    K934765
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: AUSTRALIA. CONCOMITANT MEDICAL PRODUCTS: 00625006550- BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH- 63794457, 00625006520- BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH- 64615051, 00625006520- BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH- J6963834, 00625006525- BONE SCR 6.5X25 SELF-TAP- J6925770, 110010267- G7 OSSEOTI MULTIHOLE 58MM G- 7121443, 31-323240- 3.2MMX40MM RNGLC+ ACET DRL BIT- 614350, EP-200152- ACT ARTIC E1 HIP BRG 28X46MM- 735920 AND 110024465- G7 DUAL MOBILITY LINER 46MM G- 492650. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2022-00234, 0002648920-2022-00235, 0002648920-2022-00236 AND 0002648920-2022-00238. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, REQUESTED BUT NOT RETURNED BY HOSPITAL. 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/CORRECTED UPDATED: D4; G3; H2; H3; H4; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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 PATIENT UNDERWENT LEFT HIP REVISION APPROXIMATELY 1-YEAR POST IMPLANTATION DUE TO SIGNIFICANT BONE LOSS RESULTING IN LOOSENING OF THE CUP.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959361 BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A J6923630 00889024119840

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE.