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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HD SZ 44MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Ossification (1428); Pain (1994); Local Reaction (2035); Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 10/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03788. 0001825034 - 2020 - 03789. 0001825034 - 2020 - 03791.
 
Event Description
It was reported a patient had an initial left tha. Subsequently, the patient was revised approximately 11 years later due to metallosis, pain, ho, elevated metal ion levels, altr, scar tissue, and tissue damage. The head and the taper adapter were removed and replaced. 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 44MM
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 Key10683600
MDR Text Key211473773
Report Number0001825034-2020-03790
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Model NumberN/A
Device Catalogue Number157444
Device Lot Number379100
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 Received11/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2007
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: 10/15/2020 Patient Sequence Number: 1
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