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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER STRYKER FEMORAL PLATE; PLATE, FIXATION, BONE

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STRYKER STRYKER FEMORAL PLATE; PLATE, FIXATION, BONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Non-union Bone Fracture (2369); Inadequate Osseointegration (2646)
Event Date 06/13/2014
Event Type  Injury  
Event Description
It was reported the patient was implanted with a competitor's femoral plate and allograft strut for a vancouver c fracture and required a revision due to non-union.The plate was reported to have been removed for the non-union with no issues and the plate was reported to be intact.The patient was revised to a synthes variable angle condylar plate, cables, allograft strut.The surgeon implanted a long plate which overlapped the stem and used screws aimed anterior to the stem and cables.An allograft strut was placed on the anterior aspect of the femur and cable.It was reported through x-ray that the synthes plate broke at the same location of the non-union site after the patient was instructed to apply weight as tolerated.The patient was reported to have heard a crack on (b)(6) 2014 which could have been when the plate breakage occurred.It was further reported the patient is quite small and light weighted leading the surgeon to expect the plate to support her partial weight bearing.The revision surgery was delayed as the patient was reported to be febrile.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
STRYKER FEMORAL PLATE
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER
MDR Report Key17525204
MDR Text Key321146631
Report NumberMW5132145
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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