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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. M2A MAGNUM HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: us157854 - m2a magnum cup - 376760; 103205 - taperloc femoral stem - 775170; 139254 - m2a magnum taper insert - 448250.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -09587.
 
Event Description
It was reported patient underwent hip revision approximately 9 years post implantation due to metallosis.During the surgery, the head component was found to be cold welded to the stem resulting in the removal of a well fixed stem.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
 
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Brand Name
M2A MAGNUM HEAD
Type of Device
PROSTHESIS, 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 Key7953516
MDR Text Key123297278
Report Number0001825034-2018-09588
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK833175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2017
Device Model NumberN/A
Device Catalogue Number157448
Device Lot Number491740
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/13/2018
Initial Date FDA Received10/10/2018
Supplement Dates Manufacturer Received01/25/2019
Supplement Dates FDA Received01/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2007
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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