MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Inflammation (1932); Pain (1994); Metal Related Pathology (4530)

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: cat#: 139259; m2a magnum 42-50m tpr insrt +6; lot#: 694020. Cat#: 11-103215; taperloc por fmrl lat 16x152; lot#: 600530. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00778, 0001825034-2013-04570, 0001825034-2013-04571. (this was originally reported on: 0001825034-2013-04568).

Event Description

It was reported the bilateral patient has been experiencing pain, inflammation and elevated metal ion levels. The patient had a right hip revision approximately 11. 5 years after initial surgery. The head, taper and stem were removed and replaced. No further information has been provided to date.

• Brand Name: M2A-MAGNUM MOD HD SZ 50MM
• 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: 13957401
• MDR Text Key: 288598229
• Report Number: 0001825034-2022-00779
• 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

• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 157450
• Device Lot Number: 605660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2009
• 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 Treatment Data

Date Received: 03/30/2022 Patient Sequence Number: 1