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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM TPR INSRT; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. M2A-MAGNUM TPR INSRT; PROSTHESIS, HIP Back to Search Results
Catalog Number 139258
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/04/2008
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: us157850-m2a-magnum pf cup-167780, 157444-m2a-magnum mod hd-134600, x12-171313-integral/x por-299620.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2019 -05135, 0001825034 -2019 -05136.
 
Event or Problem Description
It was reported the patient underwent an initial hip arthroplasty.Subsequently, the patient underwent a revision due to unknown reasons a year later.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 or Problem Description
No additional event information to report at this time.
 
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Brand Name
M2A-MAGNUM TPR INSRT
Common Device Name
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key9321283
Report Number0001825034-2019-05137
Device Sequence Number10859792
Product Code KWA
UDI-Device Identifier00880304428010
UDI-Public00880304428010
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
PMA/510(K) Number
K042037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2008
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/29/2020
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? No
Operator of Device Health Professional
Device Expiration Date07/31/2017
Device Catalogue Number139258
Device Lot Number228310
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/22/2019
Supplement Date Received by Manufacturer01/29/2020
Initial Report FDA Received Date11/14/2019
Supplement Report FDA Received Date01/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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