BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR SHELL, MODULAR, ø 46

    MDR report key: 19089451 · Received April 11, 2024

    Report

    Report Number
    0009613350-2024-00137
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 14, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWY
    UDI-DI
    00889024503854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: REPORT SOURCE GERMANY. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: ITEM # 61272846, MODULAR-BIPOLAR INSERT 28/46, LOT # 3173338. ITEM # 302805, PROTASUL-S-30-HEAD 28 S, LOT # 3184508. ITEM # 0106010204, AVENIR STD STEM CEMENTED 4., LOT # 3170286. THE MODULAR BIPOLAR SHELL, MODULAR BIPOLAR INSERT, AND COCR HEAD WERE RETURNED TO THE PRODUCT SURVEILLANCE TEAM FOR INVESTIGATION IN A DISASSEMBLED STATE. THE COCR HEAD EXHIBITED A LONG SCRATCH ON THE ARTICULATING SURFACE, LIKELY CAUSED DURING REVISION SURGERY. OTHER THAN ADDITIONAL MINOR SCRATCHES NOTHING CONSPICUOUS COULD BE OBSERVED. THE MODULAR BIPOLAR SHELL APPEARED UNDAMAGED, WITH NO ABNORMALITIES ON THE SIX FLUTES ALONG ITS CIRCUMFERENCE. THE MODULAR BIPOLAR INSERT SHOWED SOME SCRATCHES AND MINOR DAMAGE ALONG THE INNER AND OUTER SIDE, LIKELY RESULTING FROM THE DISLOCATION AND / OR REMOVAL. THE KNOBS OF THE INSERT AND THE METAL LOCKING RING SHOWED NO SIGNS OF DAMAGE. ADDITIONALLY, TWO IMAGES OF THE EXPLANTED DEVICES WITH BIOLOGICAL DEBRIS WERE PROVIDED. NOTHING CONSPICUOUS COULD BE IDENTIFIED ON THE PROVIDED IMAGES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. SURGICAL RECORDS FOR BOTH THE IMPLANTATION AND REVISION SURGERY WERE PROVIDED TO THE PRODUCT SURVEILLANCE TEAM AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS FOR THE IMPLANTATION SURGERY, REVEALED THAT THE PATIENT SUSTAINED A MEDIAL FEMORAL NECK FRACTURE FROM A FALL. A LATERAL APPROACH WAS USED, THE FRACTURE HEMATOMA WAS EVACUATED, AND NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED. REVIEW OF THE AVAILABLE RECORDS FOR THE REVISION SURGERY, SHOWED THAT THE PATIENT PRESENTED WITH A SHORTENED, OUTWARDLY ROTATED LEG, DIAGNOSED AS A HIP DISLOCATION. DURING THE REVISION, A DISLOCATION HEMATOMA WAS EVACUATED, THE SHELL AND INSERT WERE EASILY REMOVED, AND THE HEAD WAS STILL FIRMLY ATTACHED TO THE STEM. THE TROCHANTERIC MUSCLES WERE FOUND COMPLETELY DETACHED AND RE-ANCHORED, WITH NO INTRAOPERATIVE COMPLICATIONS NOTED. RADIOGRAPHS WERE PROVIDED TO THE PRODUCT SURVEILLANCE TEAM AND REVIEWED. THE IMAGES DATED REVEALED A DISLOCATION OF THE MODULAR BIPOLAR SHELL FROM THE HIP SOCKET, ALONG WITH A DISSOCIATION OF THE MODULAR BIPOLAR INSERT FROM THE MODULAR BIPOLAR SHELL. THE RETURNED DEVICES AND A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY FINDINGS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS REVEALED A HIP DISLOCATION ALONG WITH A DISSOCIATION OF THE MODULAR BIPOLAR INSERT FROM THE MODULAR BIPOLAR SHELL. IT CANNOT BE DETERMINED WHETHER THE DISSOCIATION OF THE COMPONENTS OCCURRED BEFORE OR AFTER THE HIP DISLOCATION. BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO CONDUCT FURTHER ANALYSIS OR DRAW DEFINITIVE CONCLUSIONS REGARDING THE ROOT CAUSE OF THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO THE INLAY AND SHELL WERE DISLOCATED.

    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 REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO DISLOCATION. DURING THE REVISION, THE HEAD WAS FOUND FIRMLY ATTACHED TO THE STEM WHILE THE BIPOLAR COMPONENTS WERE FOUND FREE IN THE JOINT. THE INITIAL STEM WAS LEFT INTACT, AND ALL OTHER COMPONENTS WERE REVISED. THE TROCHANTERIC MUSCLES WERE RE-ANCHORED FROM DISLOCATION DAMAGE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029863 BIPOLAR SHELL, MODULAR, ø 46 PROSTHESIS, HIP KWY ZIMMER GMBH N/A 3172280 00889024503854

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Female Required Intervention| H AVENIR STD STEM CEMENTED 4| PROTASUL-S-30-HEAD 28 S