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

Model Number N/A

Device Problems Material Erosion (1214); Naturally Worn (2988)

Patient Problems Pain (1994); Local Reaction (2035); Numbness (2415)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4). Item #: unknown, unknown taperloc stem, lot #: unknown. Item #: unknown, unknown magnum m2a cup, lot #: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. 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: 0001822565 - 2020 - 01241 cup.

Event Description

It was reported that the patient had a right tha and was revised three years later due to pain, elevated metal ions, increased symptoms of parkinson¿s disease, numbness and wear. Attempts have been made and no further information has been provided.

• 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: 9920959
• MDR Text Key: 186509245
• Report Number: 0001822565-2020-01243
• 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: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 157450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 04/03/2020 Patient Sequence Number: 1