BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL STEM

    MDR report key: 4112888 · Received September 17, 2014

    Report

    Report Number
    1822565-2014-01150
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    December 3, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPONENT COMPATIBILITY IS UNKNOWN. NEITHER OPERATIVE NOTES NOR X-RAYS WERE RETURNED FOR REVIEW. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN RECEIVED TO DATE. COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNKNOWN. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS 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 UNKNOWN. WITH THE INFORMATION PROVIDED, A DEFINITIVE CAUSE CANNOT BE STATED. EVALUATION 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 THA 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 INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFORMATION DID NOT ALTER PREVIOUSLY CONCLUDED COMPLAINT INVESTIGATION DETAIL. DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION TO CONFIRM THE ALLEGED/REPORTED METAL FATIGUE.

    Additional Manufacturer Narrative · 1

    REVIEW OF OPERATIVE NOTES FOUND NO COMPLICATIONS WERE NOTED. EXCELLENT FIXATION OF THE CUP WAS NOTED. AN ELEVATED LINER WAS IMPACTED INTO THE CUP WITH EXCELLENT FIT. REVIEW BY THE SURGEON ON (B)(6) 2014 DETERMINED THAT MILD SIGNS OF LOOSENING WERE NOTED. REVIEW OF THE X-RAYS CONFIRMED THE FRACTURED FEMORAL STEM. A POTENTIAL CONTRIBUTING FACTOR IS FATIGUE OF THE DEVICE DUE TO A TRAUMATIC EVENT WHERE THE PATIENT STRAINED THEIR LEG AND BACK WHILE HELPING ANOTHER PATIENT. HOWEVER, WITH THE INFORMATION PROVIDED A SPECIFIC CAUSE COULD NOT BE DETERMINED WITH CERTAINTY.

    Additional Manufacturer Narrative · 1

    REVIEW OF ADDITIONAL IMAGES RECEIVED AND PARTIAL REVISION OPERATIVE NOTES DID NOT IDENTIFY ANY ADDITIONAL CONTRIBUTING FACTORS FOR THE REPORTED ISSUE. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE PART-LOT COMBINATION FOR THE REPORTED STEM. DEVICE HISTORY RECORD REVIEW IDENTIFIED NO DEVIATIONS OR ANOMALIES IN THE MANUFACTURING PROCESS. THE ADDITIONAL INFORMATION DID NOT ALTER PREVIOUSLY CONCLUDED COMPLAINT INVESTIGATION DETAIL.

    Additional Manufacturer Narrative · 1

    REVISION SURGERY NOTES WERE PROVIDED FOR FURTHER REVIEW. AN EXTENDED TROCHANTERIC OSTEOTOMY WITH SAWS AND DRILLS WAS PERFORMED AND PROXIMAL FEMORAL PIECE WAS REMOVED WITHOUT A LOT OF DIFFICULTY. THE DISTAL FRAGMENT WAS ALSO REMOVED. HETEROTOPIC BONE WAS NOTED. THE OSTEOTOMY FRAGMENT WAS REPLACED AND 2 CABLES WERE PLACED. TRIAL COMPONENTS WERE PLACED AND THE STABILITY WAS SATISFACTORY. THE ADDITIONAL INFORMATION DID NOT ALTER PREVIOUSLY CONCLUDED COMPLAINT INVESTIGATION DETAIL.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFORMATION DID NOT ALTER PREVIOUSLY CONCLUDED COMPLAINT INVESTIGATION DETAIL.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S FEMORAL COMPONENT HAS A HAIRLINE HORIZONTAL FRACTURE.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THE PATIENT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577143 VERSYS HIP SYSTEM FEMORAL STEM HIP PROSTHESIS LZO ZIMMER, INC. 61834813

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other