BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY +5MM CO 44MM

    MDR report key: 22608185 · Received July 25, 2025

    Report

    Report Number
    0001825034-2025-02234
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    April 10, 2018
    Report Date
    November 7, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304534148
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. H11: 0001825034-2025-02231. 0001825034-2025-02232. 0001825034-2025-02233. 0001825034-2025-02235. 0001825034-2025-02236. 0001825034-2025-02631. 0001825034-2025-02632. 0001825034-2025-02633. PRODUCT HAS NOT BEEN EVALUATED AS IT HAS BEEN DETERMINED THE EVENT IS NOT RELATED TO DEVICE. ROOT CAUSE OF THE REPORTED EVENT IS NOT DEVICE RELATED. ARTHROFIBROSIS IS DEFINED AS THE DEVELOPMENT OF FIBROUS SCAR TISSUE WITHIN OR SURROUNDING A JOINT. ARTHROFIBROSIS IS A KNOWN POSTOPERATIVE PROCEDURE RELATED COMPLICATION THAT CAN OCCUR FROM SURGICAL IMPLANTATION OF NEW JOINT REPLACEMENT AS WELL AS FROM PREVIOUS INJURIES OR SURGICAL PROCEDURES. SCAR TISSUE FORMATION IS A NORMAL HEALING RESPONSE; HOWEVER, THE BUILDUP OF SUCH CAN RESULT IN PAIN, STIFFNESS, LIMITED RANGE OF MOTION, AND DIFFICULTY PROPERLY AMBULATING. IF EXCESS SCAR TISSUE DEVELOPS, CONSERVATIVE MEASURES SUCH AS EXERCISES OR PHYSICAL THERAPY WOULD BE ATTEMPTED FIRST. IF THESE ATTEMPTS FAIL, SURGICAL INTERVENTION SUCH AS MANIPULATION UNDER ANESTHESIA, ARTHROSCOPIC ARTHROLYSIS, OR OPEN ARTHROTOMY WOULD BECOME NECESSARY TO REMOVE THE FIBROUS TISSUE AND RESTORE JOINT FUNCTION. THE EVENT IS 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN GLENOID; LOT#: UNKNOWN. ITEM#: 211215, COMPR SRS PROX BDY - SM 48MM; LOT#: 965930. ITEM#: 211238, COMPR SRS MOD STEM - 12X100MM; LOT#: 092190. ITEM#: EP-115393, E1 44-36 STD HMRL BRNG; LOT#: 256980. ITEM#: 211228, COMPR SRS MOD RGX AUG - SM; LOT#: 072300. H3: CUSTOMER 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. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2. D10: 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#: 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#: UNKNOWN, UNKNOWN 42MM SCREW; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN 36MM GLENOSPHERE; LOT#: UNKNOWN. H10: RELATED REPORT NUMBER: 0001825034-2025-02231. 0001825034-2025-02232. 0001825034-2025-02233. 0001825034-2025-02235. 0001825034-2025-02236. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AND UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE APPROXIMATELY SEVEN (7) YEARS AND THREE (3) MONTHS AGO WHERE THEY HAD A MANIPULATION WITH LYSIS OF ADHESION AND ROTATOR CUFF REPAIR DUE TO LIMITED RANGE OF MOTION AND PERSISTENT PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT HAD A REVISION LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY APPROXIMATELY EIGHT (8) YEARS AND 1 MONTH AGO WITH ANOTHER REVISION APPROXIMATELY FOUR (4) MONTHS LATER DUE TO PAIN AND SCAR TISSUE. SUBSEQUENTLY, APPROXIMATELY SIX (6) YEARS AND FOUR (4) MONTHS AGO THE PATIENT HAD A MANIPULATION WITH LYSIS OF ADHESION AND ROTATOR CUFF REPAIR DUE TO LIMITED RANGE OF MOTION AND PERSISTENT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286056 COMP RVS TRAY +5MM CO 44MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 637540 00880304534148

    Patients

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