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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. M2A-MAGNUM MOD HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Insufficient Information (3190)
Patient Problems Cyst(s) (1800); Pain (1994); Osteolysis (2377); No Information (3190)
Event Date 11/22/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Reported event was unable to be confirmed due to limited information provided by the customer. The dhr was unable to be reviewed as the lot number is unknown. The root cause is unable to be determined. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01753. 0001825034 - 2020 - 01759.
 
Event Description
It was reported patient has been indicated for revision due to unknown reason; however, no revision has been reported to date. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A-MAGNUM MOD HEAD
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 Key9985838
MDR Text Key188523779
Report Number0001825034-2020-01758
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101336
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberN/A
Device Catalogue Number157454
Device Lot Number803060
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 Received03/22/2021
Was Device Evaluated by Manufacturer? Yes
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: 04/22/2020 Patient Sequence Number: 1
Treatment
UNKNOWN CUP; UNKNOWN STEM
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