MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50M TPR INSRT; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: 11-103201 ¿ taperloc femoral stem ¿ 009340; us157852 ¿ m2a magnum cup ¿ 018300; 157446 ¿ m2a magnum head ¿ 262310.Reported event was confirmed by review of operative notes.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01463.

Event Description

It was reported that patient underwent a right hip revision approximately 8 years post implantation.During the surgery, it was noted that the head was difficult to remove and there was a crack in the greater trochanter.The fracture was repaired with 2 super cables.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A-MAGNUM 42-50M TPR INSRT
• 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: 8469019
• MDR Text Key: 142341125
• Report Number: 0001825034-2019-01462
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042037
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: N/A
• Device Catalogue Number: 139258
• Device Lot Number: 557170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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