BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM G

    MDR report key: 10572308 · Received September 23, 2020

    Report

    Report Number
    0001825034-2020-03601
    Event Type
    Injury
    Date Received
    September 23, 2020
    Date of Event
    February 28, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000666-G7 PPS LTD ACET SHELL 58G-6559818, 00877503602-BIOLOX® DELTA, CERAMIC FEMORAL HEAD-3001636, 574202075-AVENIR CMPL HA HO COL SIZE7.5-2991775. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, ASSOCIATED REPORTS: 0001825034 -2020 - 03600. 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. AN I&D (INCISION & DEBRIDEMENT) COULD BE 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. AS REPORTED, THE PTS SURGICAL SITE WOUND DEHISCED, HIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS AND IT WAS REPORTED THAT MEDICAL INTERVENTION TOOK PLACE; HOWEVER, IT IS UNKNOWN THE SPECIFIC TYPE OF INTERVENTION UTILIZED. AS ALSO NOTED THE PATIENT ALSO HAS SEVERAL COMORBIDITIES: BMI IS 46 AND HAS SLEEP APNEA WHICH DECREASES OXYGENATION TO THE TISSUES WHICH IS IMPORTANT FOR HEALING. THE PATIENT IS ALSO NOTED TO BE TIRED/FATIGUED, OFTEN HUNGRY/THIRSTY, BLURRY VISION ¿ (POSSIBLE SIGNS/SYMPTOMS OF DIABETES), WHICH CAN AFFECT WOUND HEALING. (DIABETES WOULD REQUIRE DIAGNOSIS BY A PHYSICIAN OR NP). 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 · 1

    IT WAS REPORTED THE PATIENT HAD A WOUND DEHISCENCE 1-MONTH POST IMPLANTATION AT THE FOLLOW-UP VISIT. THE PATIENT HAD AN UNKNOWN MEDICAL INTERVENTION IN THE PHYSICIAN¿S OFFICE. PATIENT OUTCOME WAS NOTED AS TOLERATED. 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
    1037897 G7 NEUTRAL E1 LINER 36MM G PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6678484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention