MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 46MM PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: catalog#: us157852 m2a-magnum pf cup 52odx46id lot#: 496100, catalog#: 139259 m2a magnum 42-50m tpr insrt +6 lot#: 036980, catalog#: x11-180311 bi-metric/x por nc lat 11x135 lot#: 026860. 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: 0001825034-2022-00705, 0001825034-2022-00706, 0001825034-2022-00707.

Event Description

It was reported that the patient underwent a revision procedure of the left hip approximately eleven (11) years post implantation due to metallosis, osteolysis, pseudotumor, and a trochanteric fracture. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A-MAGNUM MOD HD SZ 46MM
• 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: 13934958
• MDR Text Key: 288098882
• Report Number: 0001825034-2022-00704
• 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

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 157446
• Device Lot Number: 908140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• 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: 03/29/2022 Patient Sequence Number: 1