BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER

    MDR report key: 8392492 · Received March 5, 2019

    Report

    Report Number
    0001822565-2019-01018
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    September 4, 2018
    Report Date
    April 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K052906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT IS CONFIRMED BASED ON THE PHOTOGRAPH OF THE EXPLANTS. REVIEW OF PHOTOGRAPHS SHOWS THE GLENOSPHERE REMAINED ASSEMBLED TO THE BASEPLATE ALONG WITH THE SCREWS. TISSUE AND BLOOD ARE OBSERVED ON THE POST OF THE BASEPLATE. THE POLY LINER SHOWED WEAR, POSSIBLY HAPPENED DUE TO DISLOCATION. BLOOD STAINS ARE OBSERVED ON THE LINER. BLOOD AND TISSUE WAS OBSERVED ON THE STEM. X-RAYS PROVIDED WERE REVIEWED STATING LOOSENING OF THE GLENOID COMPONENT WITH MALPOSITION AND LOOSENING OF THE HUMERAL COMPONENT WITH SUBLUXATION WITH RESPECT TO THE GLENOID COMPONENT, WHICH MAY RELATE TO POLYETHYLENE WEAR. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00434903611 GLENOSPHERE 36 MM DIAMETER 63028198/63040114; 00434902502 BASE PLATE 25 MM POST LENGTH +2 MM LATERAL OFFSET UNCEMENTED 63175602; 0104223024 ANATOMICAL SHOULDERÂ?¢ REVERSE, SCREW SYSTEM, 4.5-24 2740051; 0104223036 ANATOMICAL SHOULDERÂ?¢ REVERSE, SCREW SYSTEM, 4.5-36 2831766; 00434901213 HUMERAL STEM 12 MM STEM DIAMETER 130 MM STEM LENGTH 63108407. REPORT SOURCE- FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DISCARDED. 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: 0001822565 - 2019 - 01019; 0001822565 - 2019 - 01021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INITIAL SHOULDER ARTHROPLASTY AND SUBSEQUENTLY UNDERWENT A REVISION DUE TO GLENOID LOOSENING AND DISLOCATION, CAUSING RESTRICTED RANGE OF MOTION AND PAIN, WITH SECONDARY POLYETHYLENE WEAR TWO (2) YEARS, TEN(10) MONTHS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185307 POLY LINER PLUS 0 MM OFFSET 36 MM DIAMETER PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 63152436

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R