BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 11385962 · Received February 26, 2021

    Report

    Report Number
    0001822565-2021-00520
    Event Type
    Injury
    Date Received
    February 26, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K030902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO COMPLICATION DURING THE INITIAL SURGERY. X-RAY REVIEW STATES ANATOMIC ALIGNMENT OF THE RIGHT KNEE ARTHROPLASTY. THE REVIEW OF QUALITY RECORDS SHOWED THAT THE BATCHES WERE PREPARED IN ACCORDANCE WITH THE REQUIREMENTS OF OUR QUALITY MANAGEMENT SYSTEM AND ALL QUALITY CONTROL TESTS HAVE BEEN PASSED SUCCESSFULLY. BASED ON THE KNOWLEDGE AND INFORMATION AVAILABLE TO US, WE CANNOT IDENTIFY A PRODUCT DEFICIENCY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-762-22: PAIN AND LOOSENING ARE KNOWN ADVERSE EFFECTS OF THE SYSTEM. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3007963827-2021-00043; 0002648920-2021-00035; 0001822565-2021-00521. CONCOMITANT MEDICAL PRODUCT: FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT ITEM# 00576401552 LOT# 62622231; STEMMED TIBIAL COMPONENT PRECOAT SIZE 3 FOR CEMENTED USE ONLY ITEM# 00598003701 LOT# 62597023; PALACOS R 1X40 SINGLE ITEM# 00111214001 LOT# 76164320; ALL POLY PATELLA STANDARD SIZE 32 MM DIAMETER 8.5 MM THICKNESS CEMENTED ITEM# 00597206532 LOT# 62549293; ARTICULAR SURFACE SIZE EF 10 MM HEIGHT "USE WITH PLATE 3 ITEM# 00596403210 LOT# 62620682. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY, AND SUBSEQUENTLY, THE PATIENT STARTED EXPERIENCING EXTREME PAIN AND DIFFICULTY WALKING APPROXIMATELY FOUR AND A HALF YEARS POST IMPLANTATION. A BONE SCAN SHOWED LOOSENING AND THE PATIENT HAS BEEN INDICATED FOR A REVISION. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284011 PALACOS R 1X40 SINGLE BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 77884388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other