BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER OPTION TYPE 1 TPR SLEVE -3

    MDR report key: 22837756 · Received August 19, 2025

    Report

    Report Number
    3002806535-2025-00352
    Event Type
    Injury
    Date Received
    August 19, 2025
    Report Date
    January 15, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271472
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: CER BIOLOXD OPTION HD 28MM; ITEM# 650-1055; LOT# 3031481. G7 PPS LTD ACET SHELL 54F; ITEM# 010000664; LOT# 7035252. G7 DUAL MOBILITY LINER 44MM F; ITEM# 110024464; LOT# 370560. TPRLC 133 MP TYPE1 PPS HO 11.0; ITEM# 51-107110; LOT# 6883354. VIVACIT-E DM BEARING 28X44MM; ITEM# 110031012; LOT# 7035252. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; ITEM# 00625006540; LOT# 64934263. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, H11. 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. REVIEW OF COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, POST-IMPLANTATION, THE PATIENT ALLEGED EXPERIENCING MULTIPLE ISSUES, INCLUDING: EXCRUCIATING PAIN IMMEDIATELY AFTER SURGERY; A METALLIC TASTE IN THE MOUTH (WITH A CORRESPONDING NICKEL ALLERGY); A RASH ON THE LEG; SENSATIONS OF FEMORAL SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT PLUS IV ANTIBIOTICS FOR INFECTION; LIMITED MOBILITY; NUMBNESS IN THE TOES WHEN LYING ON THE SIDE; HEART ATTACK¿LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR AN UNKNOWN REASON, WHICH REPORTEDLY MADE THEM FEEL WORSE; ALLEGED PASSAGE OF A 5 MM PIECE OF METAL IN THE URINE (WHICH THE SURGEON STATED WAS MOST LIKELY A KIDNEY STONE); AND OTHER GREEN PARTICLES IN THE URINE, SUSPECTED TO BE SUTURE MATERIAL. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328288 BIOLOX DELTA CER OPTION TYPE 1 TPR SLEVE -3 HIP PROSTHESIS LZO BIOMET UK LTD. 3048758 00887868271472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11 NARRATIVE.