BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM FEMORAL HEAD

    MDR report key: 1940484 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01391
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 9, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: DEVICES WERE NOT RETURNED FOR REVIEW. X-RAYS WERE NOT PROVIDED. SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY AND REVISION SURGERY. IT IS CLEAR FROM THE SURGICAL NOTES THAT THE PT HAD SERIES OF HIP DISLOCATIONS IN THE PAST. THE PT ALSO UNDERWENT FOOT RECONSTRUCTION AND HAS UNSTABLE KNEE. THIS TYPE OF ISSUE MIGHT HAVE BEEN CAUSED DUE TO ONE OR A COMBINATION OF FOLLOWING FACTORS: FAILURE TO PRESERVE THE STRENGTH IN THE ABDUCTOR MUSCLES; FAILURE TO RESTORE LEG LENGTH AND/OR PROPER TENSION OF THE TISSUES AROUND THE TOTAL HIP; WRONG POSITIONING OF THE TOTAL HIP COMPONENTS; PRIOR MEDICAL CONDITION; NEUROMUSCULAR DISORDERS THAT DAMAGE THE MUSCLES AROUND THE TOTAL HIP; HIGH ACTIVITY LEVEL; TRAUMA; HEAVY PTS. HOWEVER THIS IS NOT AN EXHAUSTIVE LIST. NO DEFINITIVE CAUSE ANALYSIS CAN BE PERFORMED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM FEMORAL HEAD HIP PROSTHESIS LPH ZIMMER, INC. 60884554

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention POLYETHYLENE LINER: CATALOG # 00630505036,| TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED| LOT # 61575805.