BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS 3CM RESURFACING LT

    MDR report key: 16459745 · Received March 1, 2023

    Report

    Report Number
    0001825034-2023-00416
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    January 31, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304674301
    PMA / PMN Number
    K141331
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: 150446 OSS CMNTD PROX TIB STEM 13X150, LOT #: 343890; 178711 CPS/OSS 5CM TPR ADAPT W/OSS SC LOT #: 419210; 178554 CPS SHORT ANCHOR PLUG 12MM LOT #: 037950; 178538 CPS CENTERING SLEEVE 16MM LOT #: 453160; 178526 CPS TRANSVERSE PIN 6PK 28MM, LOT #: 995740; 178512 CPS NUT CO-CR-MO ALLOY, LOT #: 484670; 178367 CPS SM SHT SPDL W PINS 800LBF, LOT #: 638390; 150493 OSS REINFORCED YOKE, LOT #: 741550; 150480 OSS AXLE, LOT #: 113170; 150478 OSS POLY LOCK PIN, LOT #: 562280.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6, H10.   NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: BACKING OUT OF A SCREW AT THE DISTAL FEMORAL IMPLANT THAT EXTENDS TO THE REGION OF THE INFERIOR PATELLAR TENDON. THIS COMPLAINT HAS BEEN CONFIRMED BY THE RETURNED X-RAY IMAGES SHOWING A SCREW THAT HAS BEEN BACKED OUT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 PATIENT WHO UNDERWENT OSS OPERATION. PATIENT FELT A PAIN AROUND THE PATELLA TENDON AND WENT TO SEE A DOCTOR APPROXIMATELY 3 YEARS POST IMPLANTATION. THE DIAGNOSES CONFIRMED THE SCREW WHICH HAD CONNECTED THE FEMORAL COMPONENT AND THE STEM BACKED OUT. THE PATIENT WAS REVISED ABOUT 2 WEEKS POST DIAGNOSIS TO REMOVE/REPLACE THE SCREW. ONLY THE SCREW WAS REPLACED. THE FEMORAL IMPLANT REMAINED INTACT.

    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
    1143007 OSS 3CM RESURFACING LT PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 754980 00880304674301

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention| H SEE H10 NARRATIVE