BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E

    MDR report key: 18865616 · Received March 8, 2024

    Report

    Report Number
    0001825034-2024-00673
    Event Type
    Injury
    Date Received
    March 8, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00887868355882
    PMA / PMN Number
    K140669
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMP-09(B)(4).24966 D10: CAT# 010000999 LOT# 7612322 G7 SCREW 6.5MM X 30MM. CAT# 30103605 LOT# 66231661 G7 VIT E NEUTRAL LNR 36MM. CAT# 00877503602 LOT# 3170581 BIOLOX DELTA FEM HEAD, 36MM, +0MM. CAT# 574201060 LOT# 3158250 AVENIR CMPL HA STD COL SIZE 6. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00676.

    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. 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. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN WHAT THE PATIENT WAS EXPERIENCING WAS A RESULT OF THE ORIGINAL SURGEON REAMING OUT THE POSTERIOR WALL OF THE ACETABULUM. MEDICAL RECORDS AND/OR X-RAYS WERE NOT PROVIDED TO SUPPORT THE ALLEGATIONS. PRODUCT PLACEMENT IS THE SURGEON'S DISCRETION BASED ON PATIENT ANATOMY. THE COMPLAINT CANNOT BE CONFIRMED. 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 THE PATIENT UNDERWENT A HIP ARTHROPLASTY ON AN UNKNOWN DATE AND IS BEING CONSIDERED FOR A REVISION IN APPROXIMATELY ONE MONTH. IT WAS REPORTED THAT THE ORIGINAL SURGEON REAMED OUT THE POSTERIOR WALL OF THE ACETABULUM, THE CUP WAS THEN IMPLANTED WITH NO POSTERIOR SUPPORT, AND A VOID WAS LEFT BETWEEN THE IMPLANT AND ANTERIOR BONE. THERE WAS NO ISSUE WITH THE IMPLANT. NO ADDITIONAL INFORMATION.

    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
    741824 G7 ACETABULAR SYSTEM OSSEOTI 3 HOLE SHELL 52MM E PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 66005192 00887868355882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other