MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(6).Reported event was able to be confirmed via x-ray review.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.X-ray review of the right femur shows a fractured plate and screw fixation just distal to the proximal set of screws.The plate has a comminuted fracture of the distal femoral diaphysis without significant bone healing along the lateral aspect of the femur.A lucent fracture line is still seen.Suggestion of radiolucency is noted along the proximal most screw most distal within the plate fixation.The overall fit and alignment of the implant is appropriate.No patient contributing factors are noted.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It was reported that the patient underwent a trauma procedure with a distal femur fracture plate and is now presenting with a fracture of this plate.X-rays also show radiolucency around a screw.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN SCREW
• 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: 7323428
• MDR Text Key: 101860846
• Report Number: 0001825034-2018-01775
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• 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
• Date Manufacturer Received: 03/07/2018
• 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: N
• Patient Sequence Number: 1
• Treatment: UNKNOWN DISTAL FEMUR PLATE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR