MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN FEMORAL BROACH; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of birth: (b)(6).Report source: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial left total hip arthroplasty.While rasping the femur, a fracture of the calcar was noted.A cerclage cable was placed for stability.No further complications reported during the initial surgery.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The event was confirmed with medical records received.Review of the medical records confirms that the patient underwent a left hip arthroplasty.During the procedure it was noted that while rasping the femur, a small fissure in the calcar region is easily evidenced.Cable placed to secure the fracture.No further complications noted.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.Root cause was unable to be determined.

• Brand Name: UNKNOWN FEMORAL BROACH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9179115
• MDR Text Key: 163120559
• Report Number: 0001822565-2019-04402
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79