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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); Local Reaction (2035); Tissue Damage (2104)
Event Date 05/30/2017
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 -01813.
 
Event Description
It was reported patient underwent hip revision approximately 8 years post implantation due to a pseudotumor, metal on metal, altr, and pain. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-MAGNUM MOD HD SZ 50MM
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 Key8549153
MDR Text Key143049886
Report Number0001825034-2019-01812
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
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model NumberN/A
Device Catalogue Number157450
Device Lot Number534480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/25/2019 Patient Sequence Number: 1
Treatment
BIOMET BI-METRIC/X POR NC, CAT#X180313, LOT#750290; BIOMET M2A CUP, CATALOG#US157856, LOT#313690; BIOMET M2A MAGNUM TPR INSRT, CAT#139258, LOT#467350
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