MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM M2A MOD HEAD -6MM NK; PROSTHESIS, HIP

Model Number N/A

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

Patient Problem Blood Loss (2597)

Event Date 04/15/2004

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: 10-104062 ¿ m2a taper shell ¿ 846650; 15-105004 ¿ m2a taper liner ¿ 963340; 162307 ¿ bi-metric femoral stem - 966440; 103536 ¿ low profile screw ¿ 238880; 103533 ¿ low profile screw ¿ 000310.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 00876, 0001825034 - 2019 - 00877, 0001825034 - 2019 - 00880.

Event Description

It was reported that patient experienced approximately 1000ml of blood loss during an initial right total hip arthroplasty.During the same day, the patient underwent a revision surgery and experienced about 500ml of blood loss, for a total of approximately 1500ml in one day.No medical intervention has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 32MM M2A MOD HEAD -6MM NK
• Type of Device: PROSTHESIS, HIP
• 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: 8377966
• MDR Text Key: 137405136
• Report Number: 0001825034-2019-00879
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 11-163667
• Device Lot Number: 335980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2004
• 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