BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN PERSONA TIBIAL COMPONENT

    MDR report key: 22725029 · Received August 6, 2025

    Report

    Report Number
    0001822565-2025-02802
    Event Type
    Injury
    Date Received
    August 6, 2025
    Report Date
    April 14, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) GUNDA, B., GOLDBERG, L. ALBAN, A. STRECKER, S. MCCRACKEN, C., CARANGELO, R. J., WITMER, D. (2025) THE EFFECT OF THE DESIGN OF POLYETHYLENE INSERTS IN TOTAL KNEE ARTHROPLASTY ON PATIENT REPORTED OUTCOMES. JOURNAL OF THE AAOS GLOBAL RESEARCH & REVIEWS. 9(5)1-6 HTTPS://DOI.ORG/10.5435/JAAOSGLOBAL-D-25-00075. B3 - EVENT DATE - ARTICLE WAS PUBLISHED ON AN UNKNOWN DATE IN MAY 2025. D10 - CONCOMITANT DEVICES - UNKNOWN PERSONA ARTICULAR SURFACE CATALOG #: NI LOT #: NI, UNKNOWN PERSONA FEMORAL COMPONENT CATALOG #: NI LOT #: NI E1 - CONTACT - JOURNAL ARTICLE CORRESPONDENCE AUTHOR. THE COMPLAINANT 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 Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D2, G1, G3, G6, H1, H2, H11. H1: THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE LITERATURE MDR REPORTING REVIEW AND REMEDIATION EFFORT BASED ON MDR REPORTING PROCESS AND FDA ADVERSE EVENT REPORTING REQUIREMENT. CAPA -07984 WAS OPENED ON FEB 27, 2026 TO ADDRESS CORRECTIONS. DEVICE PERFORMANCE AND/OR RISK PROFILE ARE NOT IMPACTED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H6, H11. THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. IT IS EXPECTED THAT A WOUND HEALS IN STAGES AND SHOULD BE OF NORMAL APPEARANCE RELATED TO THE TIMEFRAME SINCE THE INCISION WAS MADE. A SURGICAL WOUND SHOULD BE WELL APPROXIMATED WITHOUT REDNESS, WARMTH, SWELLING AND/OR PURULENT DRAINAGE FOR THE DURATION OF ITS HEALING. THE EXPRESSION ¿WOUND DEHISCENCE¿ OR "NON-HEALING WOUND¿ WOULD IMPLY THAT THE APPEARANCE OF THE WOUND DEVIATES FROM HOW A SURGICAL WOUND SHOULD APPEAR. IT MAY BE RED, HAVE DRAINAGE, ADDITIONAL PAIN, WARMTH AND SWELLING AND HEALING TIME MAY BE DELAYED. THIS DEVIATION SIGNIFIES AN ALTERATION IN THE WOUND HEALING PROCESS WHICH CAN BE COMPLICATED BY PATIENT COMORBIDITIES SUCH AS DIABETES, OBESITY, SMOKING, AND OTHER CONDITIONS THAT ARE KNOWN TO SLOW A PERSON¿S ABILITY TO HEAL. WOUND COMPLICATIONS CAN BE TREATED CONSERVATIVELY OR MORE INVASIVELY WITH AN IRRIGATION AND DEBRIDEMENT (I&D), WHICH PROMOTES HEALING AT THE SITE AND PREVENTS FURTHER COMPLICATIONS. IF DEEPER EXPLORATION OF THE WOUND IS WARRANTED AND THE JOINT SPACE IS ENTERED, A POLY EXCHANGE IS TYPICALLY PERFORMED IN CONJUNCTION WITH THE I&D TO CLEAR OUT ANY DEBRIS, HEMATOMA FORMATION, OR TO PREVENT DEEP JOINT INFECTION. AS THE EVENT IS A PROCEDURE-RELATED COMPLICATION, THE ROOT CAUSE WAS DETERMINED TO BE TRACED TO NON-DEVICE RELATED FACTORS. 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 SIX (6) PATIENTS WERE READMITTED WITHIN THIRTY (30) DAYS FOLLOWING KNEE ARTHROPLASTY TO ADDRESS WOUND DEHISCENCE. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

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

    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
    621626 UNKNOWN PERSONA TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization SEE H11 NARRATIVE.