MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 52MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 01/18/2018

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 - 00012, 0001825034 - 2019 - 00014, 0001825034 - 2019 - 00015.

Event Description

It was reported patient underwent hip revision approximately 12 years post implantation due to pseudotumor.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

Reported event was confirmed with operative notes.The revision operative notes were reviewed and identified patient was revised due to pseudotumor for mom construct.Revision right hip to mdm articulation with removal and drainage of lymphocytic pseudotumor.Unroofed pseudotumor and spread out.Removed capsule of the pseudotumor without issue.Review of the device history records identified no related deviations or anomalies during manufacturing.A definitive root cause could not 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 MOD HD SZ 52MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8217208
• MDR Text Key: 132070649
• Report Number: 0001825034-2019-00013
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K833175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 157452
• Device Lot Number: 889680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: BIOMET BI-METRIC/X POR NCLOT#260940; BIOMET M2A-MAGNUM 52-60MM TPRLOT#835510; BIOMET M2A-MAGNUM PF CUP LOT#:475820; BIOMET BI-METRIC/X POR NCLOT#260940; BIOMET M2A-MAGNUM 52-60MM TPRLOT#835510; BIOMET M2A-MAGNUM PF CUP LOT#:475820
• Patient Outcome(s): Hospitalization; Required Intervention