MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TITANIUM SCREW LOW PROFILE; PROSTHESIS, EXTREMITY

Model Number N/A

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/17/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: item number: rd118860, item name: m2a cup, lot number: 011150; item number: x180314, item name: bi-metric stem, lot number: 308810; item number: 11-173665, item name: m2a head, lot number: 527970.Procedural related complications are influenced by the type of surgery, patients pre-existing comorbid state, and perioperative management.Facilities have discharge criteria that patients must meet post surgical procedure.If the discharge criteria are not met, then the patient will be kept until they are stable for discharge, and for their safety.The delayed/prolonged hospitalization is not abnormal, as side effects from anesthesia are common and typically resolve within 24-48 hours.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 patient underwent a left hip arthroplasty.During the immediate post-op period, it was noted that the patient experienced hypotension requiring a blood transfusion.No further complications were noted.No further event information available at the time of this report.

• Brand Name: TITANIUM SCREW LOW PROFILE
• Type of Device: PROSTHESIS, EXTREMITY
• 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: 10837153
• MDR Text Key: 216157395
• Report Number: 0001825034-2020-04046
• Device Sequence Number: 1
• Product Code: MBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2012
• Device Model Number: N/A
• Device Catalogue Number: 113848
• Device Lot Number: 503370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2002
• 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