NEXGEN ROTATING HINGE 5880-16-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-25 for NEXGEN ROTATING HINGE 5880-16-02 manufactured by Zimmer Inc..

Event Text Entries

[17156236] Patient admitted for revised hinge mechanism status post knee arthroplasty. Patient had bilateral total knee arthroplasties almost 4 years ago for treatment of severe hyper extension deformities and laxity of both knees, resulting from an electrocution injury when the patient was young. Records of the previous surgery from almost 4 years ago are not available. Surgeon reports that initially both knees did well with only residual 10 degrees hyper extension but in the last 6 months, right knee has gradually gone into almost 30 degrees hyper extension again. Presumed failure of the hinge mechanism; thus a custom implant was made that would allow for a one-piece hinge that would stop the knee at slight flexion rather than neutral or slight hyper extension. At office visit approximately 5 months ago, patient reported feeling like something snapped in the right knee when attempting to stand up. Since then, it has been more painful and the patient has had more difficulty walking. Patient has resumed wearing a full leg brace and uses two canes to walk. Physical exam shows hyper extension of the right knee slightly more than the left knee. X-ray showed no abnormality of femoral or tibial component on either ap or lateral view. Both stems remain well positioned and both prostheses appear to be well fixed. On physical exam approximately four months ago, the right knee was hyper extended 40 degrees. Patient went to surgery approximately 2 weeks ago for revised hinge mechanism. When the distal femur and proximal tibia were exposed, there was some blackish color to the synovium, suggesting a metal failure. The surgeon removed the bolt in the proximal tibia, which united the two-piece hinge and there discovered that the junction between the hinge and the shaft bolt had fractured and this resulted in the instability of the components. Surgeon removed the polyethylene insert in the lower position of the bolt along with the fragmented pieces of metal. The hinge bolt and mechanism were removed from the distal femur; then a new custom-made single piece hinge was inserted. The surgical procedure was completed and patient went to recovery in satisfactory condition. Patient did well post-operatively.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3494566
MDR Report Key3494566
Date Received2013-11-25
Date of Report2013-11-25
Date of Event2013-11-08
Report Date2013-11-25
Date Reported to FDA2013-11-25
Date Reported to Mfgr2013-12-02
Date Added to Maude2013-12-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameNEXGEN ROTATING HINGE
Generic NamePROSTHESIS, KNEE, HINGED
Product CodeHRZ
Date Received2013-11-25
Model Number5880-16-02
Catalog Number5880-16-02
Lot Number60832288
ID Number*
Device AvailabilityY
Device Age4 YR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER INC.
Manufacturer Address1800 WEST CENTER ST P.O. BOX 708 WARSAW IN 46581070 US 46581 0708


Patients

Patient NumberTreatmentOutcomeDate
10 2013-11-25

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