BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ACETABULAR SHELL WITH CLUSTER HOLES

    MDR report key: 2031149 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00693
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    November 17, 2010
    Report Date
    February 21, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. SURGICAL NOTES FROM THE PRIMARY SURGERY WERE PROVIDED. NO COMPLICATIONS WERE NOTED AND THE PT WAS SAID TO BE DISCHARGED IN GOOD CONDITION. POST-OP X-RAYS WERE ALSO PROVIDED. THE X-RAYS APPEAR NORMAL. THE PT WAS REVISED TO A LARGER SHELL, LINER, AND FEMORAL HEAD AND HAS NOT DISLOCATED SINCE THE REVISION. THE DISLOCATIONS MAY HAVE BEEN CAUSED BY ONE OR MORE OF THE FOLLOWING: MALPOSITIONING OF THE HIP REPLACEMENT IMPLANTS; NEUROMUSCULAR PROBLEMS OR OTHER MEDICAL CONDITIONS; EXCESSIVE WEIGHT GAIN OR PHYSICAL ACTIVITY; FAILURE TO PRESERVE STRENGTH IN THE ABDUCTOR MUSCLES; FAILURE TO RESTORE LEG LENGTH AND/OR PROPER TENSION OF THE TISSUES AROUND THE HIP; POOR QUALITY OF BONE; AND/OR PRIOR SURGERY OR FRACTURE THROUGH THE HIP JOINT. HOWEVER, A DEFINITIVE CAUSE FOR THIS ISSUE CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS REVISED DUE TO DISLOCATIONS. LINER WAS NOTED AS CRACKED DURING REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM ACETABULAR SHELL WITH CLUSTER HOLES JDI ZIMMER, INC. 61239946

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention LOT# 60984680, (B)(4)| SELF-TAPPING BONE SCREW, CATALOG# 00625006520,| VERSYS FEMORAL HEAD, CATALOG# 00801802801,| TRILOGY ACETABULAR LONGEVITY ELEVATED RIM LINER,| CATALOG# 00632004428, LOT# 60289180| LOT# 60713487, (B)(4)