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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Non-union Bone Fracture (2369)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: znn antegrade femoral nail piriformis fossa.Unknown screw.Foreign report source: (b)(6).Reported event was confirmed by review of x-rays received.Review of the available records identified left hip and femoral orthopedic hardware with incompletely healed fracture of the mid-diaphysis of the left femur.Fractured distal interlocking screw also seen.Osteopenia is seen.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 02942.

Event Description

It was reported patient was revised due to bone malunion and implant fracture.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: UNKNOWN SCREW
• Type of Device: PROSTHESIS, TRAUMA
• 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: 10407243
• MDR Text Key: 202888465
• Report Number: 0001822565-2020-02943
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 80