BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 42MM SCREW

    MDR report key: 22873227 · Received August 22, 2025

    Report

    Report Number
    0001825034-2025-02635
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    May 30, 2018
    Report Date
    October 2, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN TM BASEPLATE 25MM; LOT#: UNKNOWN. ITEM#: 211215, COMPR SRS PROX BDY - SM 48MM; LOT#: 965930. ITEM#: 211238, COMPR SRS MOD STEM - 12X100MM; LOT#: 092190. ITEM#: 115375, COMP RVS TRAY +5MM CO 44MM; LOT#: 637540. ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 256980. ITEM#: 211228, COMPR SRS MOD RGX AUG - SM; LOT#: 072300. ITEM#: UNKNOWN, UNKNOWN 36MM SCREW; LOT#: UNKNOWN. ITEM#: UKNOWN, UNKNOWN 36MM GLENOSPHERE; LOT#: UKNOWN. H3: CUSTOME HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. PRODUCT HAS NOT BEEN RETURNED. NO PRODUCT EVALUATION WAS ABLE TO BE COMPLETED. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. CELLULITIS IS A RAPID-SPREADING BACTERIAL INFECTION OF THE DERMIS AND SUBCUTANEOUS TISSUES, OFTEN CAUSED BY NORMAL SKIN FLORA OR OPPORTUNISTIC RESIDENTIAL BACTERIA, SUCH AS STREPTOCOCCUS PATHOGENS. CELLULITIS APPEARS AS LOCALIZED REDNESS, SWELLING, AND RASH THAT IS HOT AND PAINFUL TO TOUCH. THE BACTERIA ENTER THE SKIN VIA ANY CUT, ABRASION, OR BREAK IN THE SKIN, THUS PLACING POSTOPERATIVE JOINT PATIENTS AT INCREASED RISK FOR THE DEVELOPMENT OF CELLULITIS. OTHER COMORBIDITIES THAT INCREASE THE RISK FOR POST OPERATIVE DEVELOPMENT OF CELLULITIS INCLUDE SMOKING, DIABETES, POOR NUTRITION, OBESITY, POOR HYGIENE, OR CIRCULATORY PROBLEMS. CELLULITIS MAY RESOLVE ON ITS OWN WITH CONSERVATIVE TREATMENT BUT MOST OFTEN REQUIRES ADDITIONAL MEDICAL INTERVENTION, SUCH AS ORAL OR INTRAVENOUS ANTIBIOTICS, TO ERADICATE THE INFECTION. 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 AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY SEVEN (7) YEARS AND THREE MONTHS AGO WHERE A MANIPULATION WITH LYSIS OF ADHESION AND ROTATOR CUFF REPAIR DUE TO LIMITED RANGE OF MOTION AND PERSISTENT PAIN WAS PERFORMED. SUBSEQUENTLY, THE PATIENT APPROXIMATELY A MONTH AFTER THE REVISION SURGERY WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED ANTIBIOTICS. THE CELLULITIS WAS RESOLVED APPROXIMATELY TWO (2) MONTHS LATER.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666885 UNKNOWN 42MM SCREW SHOULDER PROSTHESIS/EXTREMITIES PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other| R SEE H11 NARRATIVE.