BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 OSSEOTI 3 HOLE SHELL 50MM D

    MDR report key: 12614778 · Received October 12, 2021

    Report

    Report Number
    0001825034-2021-02838
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    August 4, 2021
    Report Date
    January 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K140669
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SEROMA IS A POCKET OF CLEAR SEROUS FLUID THAT SOMETIMES DEVELOPS IN THE BODY AFTER SURGERY IN RESPONSE TO THE TRAUMA OF SURGICAL INCISIONS. THIS FLUID IS COMPOSED OF BLOOD PLASMA THAT HAS SEEPED OUT OF RUPTURED SMALL BLOOD VESSELS AND INFLAMMATORY FLUID PRODUCED BY THE INJURED AND DYING CELLS. A SEROMA WILL OFTEN RESOLVE ON ITS OWN, BUT MEDICAL INTERVENTION IS SOMETIMES REQUIRED. PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE ¿TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. THIS PATIENT IS ALSO MORBIDLY OBESE AND DIABETIC WHICH PLACES THE PATIENT AT INCREASED RISK FOR ALTERED HEALING AND POSTOP COMPLICATIONS. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 192113- ECHO POR FMRL LAT NC 13X145MM- 925290. 110024462- G7 DUAL MOBILITY LINER 40MM D- 726100. 650-1055- CER BIOLOXD OPTION HD 28MM- 3062491. 650-1067- CER OPTION TYPE 1 TPR SLEVE +3- 3048708. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2021-02839. 0001825034-2021 -02840. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. 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 PATIENT EXPERIENCED A POSTOP SEROMA APPROXIMATELY 1-MONTH POST IMPLANTATION REQUIRING ADDITIONAL MEDICAL INTERVENTION. ISSUE WAS RESOLVED 2 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512091 G7 OSSEOTI 3 HOLE SHELL 50MM D PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64964138

    Patients

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