BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD, M, 36/0, TAPER 12/14

    MDR report key: 17161804 · Received June 20, 2023

    Report

    Report Number
    0009613350-2023-00314
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    December 24, 2022
    Report Date
    July 24, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LPH
    UDI-DI
    00889024386495
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ G7 LONGEVITY NEUTRAL 36MM G; ITEM# 20103607; LOT# 65055483. CLS SPOTORNO, STEM, 135, UNCEMENTED, 11.25, TAPER 12/14; ITEM# 29.00.39-112; LOT# 3089797. G7 OSSEOTI 4 HOLE SHELL 60MM G; ITEM# 110010248; LOT# 7051674. G2 ¿ FOREIGN ¿ SWEDEN. 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 AND/OR CORRECTED INFORMATION. SURGERY NOTES OF THE INITIAL RIGHT THA WERE PROVIDED AND ASSESSED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. A TOTAL OF 8 IMAGES WERE PROVIDED AND ASSESSED. AP PELVIS AND CROSS-TABLE LATERAL IMAGES TAKEN BEFORE THE INITIAL SURGERY SHOW SEVERE RIGHT HIP OSTEOARTHRITIS WITH BONE-ON-BONE APPOSITION AND LATERAL FEMORAL HEAD UNDER COVERAGE. AP PELVIS AND CROSS-TABLE LATERAL IMAGES TAKEN BEFORE THE INITIAL SURGERY AFTER INITIAL SURGERY SHOW A RIGHT HIP ARTHROPLASTY WITH IMPLANTS ANATOMICALLY ALIGNED. THE RIGHT HIP ACETABULAR CUP ABDUCTION ANGLE MEASURES APPROXIMATELY 38 DEGREES. NO ABNORMALITY OF IMPLANT PLACEMENT IS NOTED. AP PELVIS AND CROSS-TABLE LATERAL IMAGES TAKEN BEFORE CLOSED REDUCTION SHOW A SUPEROLATERAL RIGHT HIP ARTHROPLASTY DISLOCATION WITH NO SIGNS OF FRACTURE. 2 IMAGES 6 WEEKS POST REDUCTION WERE ASSESSED BUT NOT HERE REPORTED AS THEY DO NOT PROVIDE ANY ADDITIONAL INFORMATION TO THE INVESTIGATION. THE INFORMATION PROVIDED DO NOT CHANGE THE OUTCOME OF THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PATIENT IS MALE AND BORN IN 1972, 179 CM AND 88 KG (BMI 27.5). THE PATIENT UNDERWENT AN INITIAL RIGHT THA DUE TO OSTEOARTHRITIS. EIGHT (8) DAYS LATER THE PATIENT SUFFERED OF A RIGHT HIP DISLOCATION. THE DISLOCATION WAS FIXED WITH A CLOSED REDUCTION. WITH THE AVAILABLE INFORMATION, 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A CLINICAL STUDY THAT A PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION AND UNDERWENT A CLOSED REDUCTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS ANTERIOR DISLOCATION FIVE (5) DAYS POST-OP WHILE SITTING ON COACH AND LIFTING THE PELVIS. IT WAS REDUCED AT THE ER IN LUND. THERE HAS NOT BEEN ANY FURTHER PROBLEMS WITH THE HIP. THE PATIENT WAS ADVISED TO AVOID EXTERNAL ROTATION WITH HIS LEG EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546440 COCR HEAD, M, 36/0, TAPER 12/14 HIP PROSTHESIS LPH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3131411 00889024386495

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Other SEE H10 NARRATIVE.