BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 36MM F

    MDR report key: 18443821 · Received January 4, 2024

    Report

    Report Number
    0001825034-2024-00019
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    August 30, 2023
    Report Date
    April 18, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2024-00018 AND 0001825034-2024-00020. D10: CAT #: 110017105 / G7 FINNED 4 HOLE SHELL 56F / LOT #: 6215509. CAT #: 51-104110 / TPRLC 133 T1 PPS HO 11X142MM / LOT #: 6232281. CAT #: 6501057 / CER BIOLOXD OPTION HD 36MM / LOT #: 2934974. CAT #: 6501064 / CER OPTION TYPE 1 TPR SLEVE -6 / LOT #: 2912967. 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 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/CORRECTED AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES: 1 YEAR FOLLOW-UP VISIT ¿ NO UPDATES RECORDED; VISIT MISSED BY PATIENT. 3 YEAR FOLLOW-UP VISIT ¿ REGULARLY PARTICIPATES IN MODERATE ACTIVITIES, UNLIMITED WALKING DISTANCE ¿ NO GAIT ISSUES, NO PROBLEMS WITH DAILY ACTIVITIES ¿ NO SUPPORTIVE DEVICES REQUIRED ¿ NO PAIN. 5 YEAR FOLLOW-UP VISIT ¿ REGULARLY PARTICIPATES IN ACTIVE EVENTS ¿ REPORTS MODERATE PAIN, ESPECIALLY WITH HIP FLEXION ¿ REPORTS MILD-MODERATE DIFFICULTY WITH ACTIVITIES OF DAILY LIVING ¿ MODERATE DIFFICULTY WALKING FOR EXTENDED PERIODS AND MODERATE TROUBLE CLIMBING STAIRS ¿ LIMPS MOST OF THE TIME ¿ AE-DIAGNOSIS OF TENDONITIS TREATED WITH NSAID, PHYSICAL THERAPY, AND CORTISONE INJECTIONS- BELIEVED TO BE RELATED TO ACETABULAR COMPONENT SPECIFICALLY ¿ *NOTED THAT AN AE WAS ALSO ENTERED FOR UNRELATED/CONTRALATERAL L HIP-WORSENING OSTEOARTHRITIS ¿ DOCUMENTED AS RESOLVED. APPROXIMATELY 5 YEARS POST OP OFFICE VISIT ¿ PATIENT REPORTS BILATERAL HIP PAIN 6/10, TAKES OTC ALEVE AS NEEDED ¿ X-RAYS ¿ IMPLANTS IN SATISFACTORY POSITION WITHOUT COMPLICATIONS ¿ CORTISONE INJECTIONS ORDERED FOR BOTH HIPS FOR ARTHRITIS IN THE LEFT AND TENDINITIS IN THE RIGHT. APPROXIMATELY 5 YEARS POST OP OFFICE VISIT ¿ HIP INJECTIONS WERE ORDERED BUT NOT GIVEN AT LAST APPOINTMENT, STILL REPORTS 7/10 PAIN. APPROXIMATELY 5 YEARS POST OP - INJECTIONS ¿ INJECTIONS REORDERED AND ADMINISTERED APPROXMATELY 5 YEARS - OFFICE VISIT ¿ PATIENT REPORTS THAT INJECTIONS PROVIDED SIGNIFICANT RELIEF FOR ABOUT A WEEK, OTC AND PRESCRIPTION ANTI-INFLAMMATORIES FURTHER RELIEVE PAIN ¿ PATIENT HAS RESTARTED FORMAL OUTPATIENT PHYSICAL THERAPY ¿ CONTINUES TO HAVE PAIN WITH ACTIVE HIP FLEXION WHICH IS ALLEVIATED WITH REST ¿ X-RAYS ORDERED TO ASSESS ACETABULAR POSITION BUT AT THIS TIME, PATIENT WILL CONTINUE CONSERVATIVE TREATMENT, NSAIDS AND PT, FOLLOW UP IN 6-8 WEEKS. APPROXIMATELY 5 YEARS POST OP - ¿ PER DR. EMERSON ¿RELATED TO ACETABULAR COMPONENT ONLY¿. COMPLAINT IS CONFIRMED VIA THE EVALUATIONS OF THE PROVIDED MEDICAL RECORDS. A DEFINITIVE 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 · 0

    IT WAS REPORTED DURING A CLINICAL STUDY THAT AT THE PATIENT¿S FIVE-YEAR FOLLOW-UP APPOINTMENT, THE PATIENT WAS EXPERIENCING PAIN, DIFFICULTY WITH AMBULATION AND COMPLETING DAILY ACTIVITIES; AND WAS DIAGNOSED WITH TENDONITIS. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, AND A STEROID INJECTION. THE ISSUE HAS BEEN CONSIDERED RESOLVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A CLINICAL STUDY THAT AT THE PATIENT¿S FIVE-YEAR FOLLOW-UP APPOINTMENT, THE PATIENT WAS EXPERIENCING PAIN, DIFFICULTY WITH AMBULATION AND COMPLETING DAILY ACTIVITIES; AND WAS DIAGNOSED WITH TENDONITIS. THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION, PHYSICAL THERAPY, AND A STEROID INJECTION. THE ISSUE HAS BEEN CONSIDERED RESOLVED. AT THE THREE-MONTH FOLLOW-UP APPOINTMENT, THE PATIENT NOTED TEMPORARY RELIEF FROM THE INJECTION BUT IS STILL EXPERIENCING PAIN DURING ACTIVE FLEXION OR ACTIVITY. THE PATIENT IS MAINTAINING CONSERVATIVE TREATMENT MODALITIES AND PHYSICAL THERAPY.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606839 G7 NEUTRAL E1 LINER 36MM F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. NI 6292613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H10 NARRATIVE