MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). 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 - 2019 - 01812.

Event Description

It was reported patient underwent hip revision approximately 8 years post implantation due to a pseudotumor, metal on metal, altr, and pain. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: M2A-MAGNUM PF CUP 56ODX50ID
• 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: 8549158
• MDR Text Key: 143050600
• Report Number: 0001825034-2019-01813
• 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,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: US157856
• Device Lot Number: 313690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 04/25/2019 Patient Sequence Number: 1

Treatment

BIOMET BI-METRIC/X POR NC CAT#X180313 LOT#750290; BIOMET M2A HEAD CATALOG#157450 LOT#534480; BIOMET M2A MAGNUM TPR INSRT CAT#139258 LOT#467350