MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERIARTICULAR PLATES & SCREWS; PLATE, FIXATION

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Report source, literature - yoo, j.Et al (2017).Low energy fractures: what is the difference? specific features and clinical outcomes by minimally invasive locking plates.Biomedical research, 28(1): 484-488.The reported event could not be confirmed based on limited information received.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.The compatibility check and complaint history search were not performed.A definitive root cause cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Product location unknown.

Event Description

It was reported in a journal article that four implant failures occurred within three months after surgery possibly due to improper implant selection and inattention to the principles of lcp.Furthermore, it was concluded that three out of four implant failures might have been caused by high plate-screw density and insufficient fixation of the proximal fragment owing to the use of short plates.Insufficient fixation might have been aggravated by the use of unicortical locking screw as the proximal end screw in two of the cases.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN PERIARTICULAR PLATES & SCREWS
• Type of Device: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7226667
• MDR Text Key: 98517816
• Report Number: 0001822565-2018-00481
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other