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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TAPER ADAPTER PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM TAPER ADAPTER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 06/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 157446, m2a-magnum mod hd, lot # 368180. Item # us157852, m2a-magnum pf cup, lot # 451740. Item # 21-103205, ha taperloc por fmrl, lot # 482210. Multiple reports have been submitted for this event. Please see associated reports: 0001825034-2018-11393, 0001825034-2018-08995, 0001825034-2018-08994.
 
Event Description
It was reported that a patient required blood transfusion of 2 units during a revision surgery. Attempts have been made, and no further information has been provided.
 
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Brand NameM2A-MAGNUM TAPER ADAPTER
Type of DevicePROSTHESIS, 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 Key8196995
MDR Text Key131420454
Report Number0001825034-2018-11531
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2015
Device Model NumberN/A
Device Catalogue Number139256
Device Lot Number684630
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
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