MAUDE Adverse Event Report: STRYKER HOWMEDICA OSTEONICS CORP TROCHANTERIC GRIP PLATE; PLATE, FIXATION, BONE

Catalog Number 3704-2-082

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/10/2019

Event Type  Injury  

Event Description

Date: (b)(6) 2019 revision right total hip for peri prosthetic fracture.Broken solution stem- spontaneous- please investigate reason for same.Surgeon requested investigation.Date of previous surgery (b)(6) 2018, surgeon: (b)(6), hospital: (b)(6) hospital, (b)(6) (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TROCHANTERIC GRIP PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER HOWMEDICA OSTEONICS CORP
• MDR Report Key: 17526538
• MDR Text Key: 321137162
• Report Number: MW5133477
• 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: 10/12/2022

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
• Device Catalogue Number: 3704-2-082
• Device Lot Number: G7437405
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1