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

Catalog Number 157446

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Host-Tissue Reaction (1297); Reaction (2414)

Event Date 05/16/2019

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 # us157852/ m2a-magnum pf cup / lot # 420180; item # 13-103207/ taperloc por red/lat /lot # 747020; item# 139256/ m2a-magnum 42-50 tpr insrt std/ lot# 907020.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2020 -01926, 0001825034 -2020 -01929, 0001825034 -2020 -01930.

Event Description

It was reported the patient underwent a left hip revision surgery approximately 7 years post implantation due in vivo corrosion, metallosis, and pseudotumor.Head, stem and taper were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g4, g7, h2, h3, h6, h10 the event was confirmed with medical records received.Review of the available records identified the following: findings: general anesthesia, 300ml ebl, 64 yr old, metallosis, large cavity lined with dark grey tissue consistent with metallosis (10x8x10cm), pseudotumor, stem well fixed, removed modular ball component, black debris at the articulation consistent w/metallosis, morse taper removed, elected to revised the femoral component, used clerage wires while reaming to prevent fracture, shell well fixed & retained.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.

Event Description

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

• 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: 10032141
• MDR Text Key: 193396915
• Report Number: 0001825034-2020-01928
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 157446
• Device Lot Number: 366190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 78