BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 3518945 · Received November 26, 2013

    Report

    Report Number
    1822565-2013-01703
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    August 10, 2015
    Report Date
    July 12, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER SURGICAL NOTES NOR X-RAYS WERE RETURNED TO ASSESS COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENT INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. WITH THE INFO PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    UPON RECIEVING NEW INFORMATION, IT WAS FOUND THAT THE PRODUCT WAS MANUFACTURED BY ZIMMER (B)(4). PLEASE REFERENCE 0002648920-2016-00863.

    Additional Manufacturer Narrative · 1

    THE REPORTED SHELL POROUS WITH CLUSTER HOLES 50 MM O.D., IS ASSOCIATED WITH A 2012 CORRECTION (B)(4). THE REASON FOR RECALL: ZIMMER INC. IS INITIATING A CORRECTION OF CERTAIN TRILOGY ACETABULAR SYSTEM SHELLS WITHOUT HOLES. DEVICE WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. REVIEW OF REVISION SURGICAL NOTES INDICATED THAT THE PATIENT UNDERWENT A LEFT THA REVISION DUE TO CHRONIC PAIN OF THE LEFT HIP. THE FINDINGS WERE NOTED: POSITIVE PSEUDOTUMOR IDENTIFIED BETWEEN GLUTEUS MEDIUS AND THE LATERAL GREATER TROCHANTER HAS HAD EVIDENCE OF NECROTIC TISSUE PATHOLOGY SHOWED NO EVIDENCE OF ACUTE INFLAMMATORY CELLS OR HISTIOCYTES; EXTERNAL ROTATOR CAPSULAR FLAP APPEARED TO BE WELL HEALED WITH CLEAR FLUID SYNOVIAL TISSUE IN THE JOINT SHOWED NO EVIDENCE OF ACUTE INFLAMMATORY CELLS; POLYETHYLENE WAS REMOVED TO FIXATION SCREWS WERE REMOVED SOCKET WAS FIXED WITH ONLY A FIBROUS INGROWTH CAPPING ON THE SOCKET WITH A BONE TAMP THE SOCKET CAME OUT WITH NO EVIDENCE OF BONE INGROWTH BETWEEN THE SOCKET AND BONE; UPON REMOVING THE FEMORAL HEAD, THERE IS EVIDENCE OF CORROSION ON THE NECK OF THE TRUNNION AS WELL AS ON THE FEMORAL HEAD THIS IS EASILY WIPED OFF. IT IS NOTED IN THE TECHNIQUE SECTION THAT THE PATIENT WAS TREATED WITH CONVERSION TO COMPETITOR DEVICES. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED AND THE PATIENT TOLERATED TH PROCEDURE WELL AND WAS DELIVERED TO PACU IN STABLE CONDITION. THIS DEVICE WAS USED FOR TREATMENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED ROOT CAUSE WAS UNABLE TO 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 · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING HIP PAIN AND HAVING TROUBLE WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615931 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWY ZIMMER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other