BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW 6.5MM X 35MM

    MDR report key: 5968081 · Received September 21, 2016

    Report

    Report Number
    0001825034-2016-03746
    Event Type
    Injury
    Date Received
    September 21, 2016
    Date of Event
    November 28, 2016
    Report Date
    May 29, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES AND X-RAYS. PER THE REVISION OPERATIVE NOTES, THE PATIENT HAD MECHANICAL FAILURE WITH SEVERE BONE LOSS. THE GLENOSPHERE AND BASEPLATE WERE LOOSE WITH A LARGE DEFECT. PER THE CT SCAN RESULTS, THERE WAS SUPERIOR DISPLACEMENT OF THE SCAPULAR COMPONENT WITH ASSOCIATED 18MM BONY FRAGMENT SUGGESTIVE OF A MODERATELY DISPLACED FRACTURE FROM THE ANTERIOR ASPECT OF THE GLENOID AND SCAPULAR SPINE. THERE APPEARS TO BE A NONDISPLACED FRACTURE THROUGH THE BASE OF THE CORACOID PROCESS AS WELL. PER THE X-RAY REVIEW, "COMPLAINT SUGGESTS LOOSENING OF ALL THE SCREWS. THIS COULD BE IDENTIFIED RADIOGRAPHICALLY AS PERIPROSTHETIC LUCENCIES SURROUNDING THE SCREWS. THE ONLY IMAGES THAT SHOW THE SCREWS ARE 1, 2, AND 5. NONE OF THESE IMAGES REVEAL THIS TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4). CONCOMITANT MEDICAL PRODUCT - BIOMET COMPREHENSIVE HUMERAL TRAY WITH LOCKING RING CATALOG#: 115370 LOT #:910020, BIOMET COMPREHENSIVE MINI HUMERAL STEM CATALOG #113630 LOT#836390, BIOMET HUMERAL BEARING CATALOG # XL-115363 LOT#502530.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 3 STATES, "INTRAOPERATIVE BONE PERFORATION OR FRACTURE MAY OCCUR, PARTICULARLY IN THE PRESENCE OF POOR BONE STOCK CAUSED BY OSTEOPOROSIS, BONE DEFECTS FROM PREVIOUS SURGERY, BONE RESORPTION, OR WHILE INSERTING THE DEVICE." NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION AND/OR EXCESSIVE ACTIVITY." NUMBER 13 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03745 / 03746 / 03747).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A RIGHT SHOULDER REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURES AND WEAR. PRIOR TO THE REVISION, THE SURGEON ALSO ALLEGEDLY NOTED THAT THE INITIAL COMPONENTS WERE MALPOSITIONED. THE STEM REMAINED IMPLANTED AND ALL OTHER COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT SHOULDER REVISION PROCEDURE MAY OCCUR APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO ALLEGED PAIN, SWELLING, LOOSE SCREWS, AND BONE FRACTURE; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED REPORTED MALPOSITIONING OF COMPONENTS DURING THE INITIAL PROCEDURE MAY HAVE CONTRIBUTED TO INDICATED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619474 COMPREHENSIVE REVERSE SHOULDER CENTRAL SCREW 6.5MM X 35MM PROSTHESIS, SHOULDER SCREW KWS BIOMET ORTHOPEDICS N/A 162000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R