MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 42-50 TPR INSRT STD; PROSTHESIS HIP

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: m2a-magnum mod hd # item 157444 lot 012410.Ref 103204 lot 060690 taperloc femoral 10x140mm.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03064.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a revision surgery, the femoral head could not be released from the taper neck, leading to revision of the well-fixed femoral stem.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Medical records were received, however the event could not be confirmed.Medical records noted stem was well fixed.After multiple attempts, the stem was able to be removed.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 42-50 TPR INSRT STD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8796021
• MDR Text Key: 151221053
• Report Number: 0001825034-2019-03065
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 139256
• Device Lot Number: 916710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1