BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH MULTIHOLES

    MDR report key: 1270557 · Received December 17, 2008

    Report

    Report Number
    1822565-2008-00918
    Event Type
    Injury
    Date Received
    December 17, 2008
    Date of Event
    July 28, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ZIMMER, INC
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE ALLEGED COMPLAINT REFERS TO MULTIPLE REVISIONS OF THE LEFT HIP REPLACEMENT. THE PT'S RECOVERY HAS BEEN INHIBITED BY RECURRENT AND PERSISTENT INFECTION. NO DEVICES, PHOTOS, AND/OR X-RAYS WERE RETURNED FOR EVALUATION. LIMITED PATIENT DATA WAS SUPPLIED, AND CONSEQUENTLY THE LACK OF RELEVANT MEDICAL CONDITIONS THAT MAY HAVE INFLUENCED PRODUCT PERFORMANCE. THE ACETABULAR COMPONENT, SCREWS, AND SUPERIOR AUGMENT WERE REPORTED GROSSLY LOOSE. WITH THE INFO PROVIDED, IT IS PROBABLE THAT THE PERSISTENT INFECTION DID NOT ALLOW FOR BONE IN-GROWTH OR PROPER SEATING. RESULTS NO PRODUCT WAS RETURNED. 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. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007 AND THAT THE PATIENT WAS REVISED IN 2008. THE PT HAD MULTIPLE REVISIONS OF LEFT TOTAL HIP REPLACEMENT. RECOVERY COMPLICATED BY RECURRENT AND PERSISTENT INFECTION. HARDWARE REMOVED 8 MONTHS AFTER PLACEMENT. WHEN REMOVED THE FOLLOWING WAS FOUND DURING SURGERY: WHEN HIP JOINT WAS EXPOSED AND THERE WAS A LARGE AMOUNT OF BROWNISH-APPEARING FLUID. THE FEMORAL HEAD WAS REMOVED. THE ACETABULAR COMPONENT WAS EXPOSED. IT WAS GROSSLY LOOSE AND IN A VERTICAL POSITION, ALONG WITH ITS SCREWS. THIS WAS REMOVED EASILY. THE SUPERIOR AUGMENT WAS ALSO GROSSLY LOOSE AND THIS WAS REMOVED. TWO OR THREE SCREWS WERE STILL LODGED IN THE PELVIC BONE. IT WAS APPARENT THAT THESE HAD CUT THROUGH THE ACETABULAR AUGMENT, WHICH HAD TWO LARGE DEFECTS WITHIN THE MIDDLE RELATED TO THIS. THESE SCREWS WERE REMOVED. A LONG MODULAR FEMORAL STEM WAS IN PLACE. THE TAPER WAS DISRUPTED IN THE USUAL MANNER AND THE PROXIMAL BODY WAS REMOVED. LARGE TREPHINES WERE THE PASSED OVER THE DISTAL STEM, WHICH HAS BEEN WELL FIXED. THE STEM WAS ULTIMATELY ABLE TO BE LOOSENED AND REMOVED WITH A SLAP HAMMER. POST RECOVERY FROM SURGERY PT DISCHARGED TO REHAB FACILITY. TWO MONTHS AFTER SURGERY, PATIENT EXPERIENCED A FALL AT HOME WHICH RESULTED IN A FRACTURE OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR ACETABULAR SYSTEM SHELL WITH MULTIHOLES HIP PROSTHESIS KWB ZIMMER, INC NA 60597644

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R| S CATALOG #00625006525| CATALOG #00625006525| LOT #60490683| CATALOG #00625006515| LOT #60652053| LOT #60655715| CATOLOG #06625006520| LOT #60740474| LOT #60746593| CATALOG #00625006525| LOT #60710594| CATALOG #00801804002| LOT #56345000| LOT #60755354| CATALOG #00630506040| LOT #60527327| CATALOG #00999801935| CATALOG #00625006520| CATALOG #00998201923| LOT #60294736