BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 9952958 · Received April 13, 2020

    Report

    Report Number
    0001825034-2020-01627
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 13, 2020
    Report Date
    August 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G4; H2; H3; H4; H6. MEDICAL REVIEW OF THE REPORTED EVENT CONCLUDED THAT IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION 'WOUND CONCERNS' OR 'NON-HEALING WOUND' WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM WHAT A SURGICAL WOUND SHOULD APPEAR AS. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AS WELL AS HEALING TIME MAY BE DELAYED. IT IS NOTED AN I&D (INCISION & DEBRIDEMENT) WAS PERFORMED ON THE SUPERFICIAL NON-HEALING WOUND. AN I&D PROCEDURE CAN BE USED TO PROMOTE THE HEALING PROCESS, AND THIS IS A COMMON PROCEDURE USED TO TREAT A NON-HEALING INCISION SITE. 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: 010000858 ¿ G7 NEUTRAL LINER ¿ 6623312, 192109 ¿ ECHO STEM ¿ 925910, 12-115120 ¿ CERAMIC HEAD ¿ 2986013. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT REMAINS IMPLANTED. 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 - 2020 - 01628. 0001825034 - 2020 - 01629.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED DELAYED WOULD HEALING AND DRAINING APPROXIMATELY 1 MONTH POST INITIAL RIGHT TOTAL HIP ARTHROPLASTY. APPROXIMATELY 3 WEEKS LATER, A SUPERFICIAL IRRIGATION AND DEBRIDEMENT WAS PERFORMED FOR WOULD DEHISCENCE. THE OUTCOME IS PENDING. NO REVISION OF DEVICES HAS BEEN REPORTED TO DATE. 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
    417795 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 662979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other