MAUDE Adverse Event Report: ZIMMER ZIMMER PERIARTICULAR PLATE; PLATE, FIXATION, BONE

Device Problem Insufficient Information (3190)

Patient Problem Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

Burgula, m.V., doshi, h.K., murphy, d.P., wenxian, p., clinical outcomes of distal femoral fractures in the geriatric population using locking plates with a minimally invasive approach, geriatric orthopaedic surgery and rehabilitation (2013), 4(1) pp.16-20.Patients experienced failure of achieving full extension postoperatively (14 patients).Extension deficit (inability to achieve full extension) of 5? to 10? was present in 12 patients and a lack of 30? in 2 patients.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ZIMMER PERIARTICULAR PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER
• MDR Report Key: 17525922
• MDR Text Key: 321069215
• Report Number: MW5132862
• 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: 09/15/2015

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