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

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).

• Brand Name: STRYKER FEMORAL PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER
• MDR Report Key: 17525204
• MDR Text Key: 321146631
• Report Number: MW5132145
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 08/12/2023
• Patient Sequence Number: 1