BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10MM

    MDR report key: 18040574 · Received October 31, 2023

    Report

    Report Number
    3007963827-2023-00297
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    May 3, 2023
    Report Date
    February 1, 2024
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    UDI-DI
    00889024243750
    PMA / PMN Number
    K121771
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS & MDRS: 42500606002 FEMUR CEMENTED POSTERIOR STABILIZED STD RT SZ 6, LOT# 65020929. MDR: 3007963827-2023-00296. 42532007102 TIBIA CEMENTED 5 DEGREE STEMMED RT SIZE E, LOT# 65046976. MDR: 3007963827-2023-00298. 42540200032 ALL-POLY PATELLA CEMENTED 32 MM DIA, LOT# 65134432. MDR: 0002648920-2023-00263.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: OFFICE VISIT 1: SMALL KNEE EFFUSION, PAINFUL GAIT WITH SEVERE LIMP, X-RAY: COMPONENTS IN GOOD POSITION AND ALIGNMENT- NO EVIDENCE OF LOOSENING; OP-NOTES: NO INTRA-OP COMPLICATIONS IDENTIFIED IN PARTIAL OP NOTE PROVIDED, SEVERE SCAR TISSUE NOTED WITH PATELLA BAJA, PATELLA AND QUADRICEP TENDONS WERE COMPLETELY INTACT WITHOUT INJURY. COMPLAINT IS CONFIRMED FROM THE PROVIDED MEDICAL RECORDS. 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 A PATIENT COMPLAINED OF PAIN, SWELLING, LIMITED EXTENSION, SEVERE LIMP, AND CHRONIC QUADRICEPS WEAKNESS. THE SURGEON SUSPECTED A QUADRICEPS TENDON TEAR. APPROXIMATELY ONE YEAR, SIX MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION WHERE SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED DUE TO PATELLA BAJA BUT ALL PATELLA AND QUADRICEPS TENDONS WERE FOUND INTACT. THE FEMORAL, TIBIA, AND POLY WERE REVISED WITH COMPETITOR PRODUCTS. THE PATELLA WAS NOT REVISED. THE PATIENT IS ALLEGING HER COMPONENTS WERE TOO LARGE.

    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
    2226469 ARTICULAR SURFACE FIXED BEARING (PS) RIGHT 10MM PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 65004577 00889024243750

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R SEE H10 NARRATIVE.