BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD SSK PSC INTLK FMRL 60 RT

    MDR report key: 5812059 · Received July 21, 2016

    Report

    Report Number
    0001825034-2016-02672
    Event Type
    Injury
    Date Received
    July 21, 2016
    Report Date
    March 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS," AND, "IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS, OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." ADDITIONAL EVENT(S) FOR THIS PATIENT REPORTED ON MEDWATCH NUMBER(S) 1825034-2016-02673 / 02686. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL PRODUCT: BIOMET ILOK STEMMED TIBIAL TRAY 67 MM PART: 141512 LOT: 321280. VANGUARD SSK PSC TIBIAL BEARING S 20X63/67 PART: 183830 LOT: 615440. MAXIM TIBIAL AUGMENT BLOCK 10 X 67 MM PART: 141762 LOT: 752390. BIOMET GB KNEE STEM 16 X 120 PART: 148186 LOT: 465670. VANGUARD DISTAL FEMORAL AUGMENT 60 X 10 RL/LM PART: 184182 LOT: 155090. VANGUARD DISTAL FEMORAL AUGMENT 60 X 10 LL/RM PART: 184202 LOT: 828110. BIOMET GB KNEE STEM 14 X 120 PART: 148184 LOT: 465660. VANGUARD POSTERIOR FEMORAL AUGMENT 60 X 5 RL/LM PART: 184142 LOT: 655140. (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE X-RAY EVALUATION REPORT CONFIRMS THAT THERE WAS OSSEOUS EXPANSION OF THE DISTAL FEMORAL MEDULLARY CAVITY SURROUNDING THE FEMORAL STEM WITH CORTICAL BREACH AT THE SITE. THE REPORT STATED THAT IT IS MOST LIKELY TO BE PSEUDO TUMOR RELATED TO OSTEOLYSIS. THE REPORT ALSO SUGGESTS THAT THERE IS FOCAL CORTICAL LUCENCY AT THE MEDIAL TIBIAL CONDYLE. THERE WAS A SMALL KNEE JOINT EFFUSION PRESENT. THERE WERE NO COMPATIBILITY ISSUES NOTED WITH THE PRODUCTS REPORTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. 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 · 1

    PATIENT HAS BEEN INDICATED FOR A REVISION DUE TO KNEE AND THIGH PAIN AND OSTEOLYSIS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465207 VNGD SSK PSC INTLK FMRL 60 RT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 535470

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention