MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MODULAR HEAD; PROSTHESIS HIP

Catalog Number 157450

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

Patient Problems Host-Tissue Reaction (1297); Osteolysis (2377); Reaction (2414); Metal Related Pathology (4530)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: item # us257856/ magnum trispike cup / lot # 868300; item# 13-103207/ taperloc por red/lat / lot # 829520; item # 139256/ m2a-magnum 42-50 tpr insrt/lot # 419790.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2021 -00419.

Event Description

It was reported that patient underwent right hip revision surgery approximately 11 years post implantation due to metallosis, pseudotumor, osteolysis and implant wear.The head was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 reported event was confirmed by review of medical records noting the patient has a large pseudotumor, gross metallosis with yellow-brown liquid and osteolysis around the proximal femur.Dhr was reviewed and no discrepancies were found.The root cause is 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.

• Brand Name: M2A-MAGNUM MODULAR HEAD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11312895
• MDR Text Key: 231310799
• Report Number: 0001825034-2021-00421
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K042037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 157450
• Device Lot Number: 805700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention