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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A MAGNUM 42-50M TPR INSRT +6 PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A MAGNUM 42-50M TPR INSRT +6 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)
Event Date 03/11/2021
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 - 2021 - 02938, 0001825034 - 2021 - 02940.
 
Event Description
It was reported that the patient underwent a right hip revision. Subsequently, patient started experiencing pain and was revised approximately 15 years later due to pain, tenderness, fluid collection, and decreased mobility. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A MAGNUM 42-50M TPR INSRT +6
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 Key12696188
MDR Text Key278322387
Report Number0001825034-2021-02939
Device Sequence Number1
Product Code KWY
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number139259
Device Lot Number221060 
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/26/2021 Patient Sequence Number: 1
Treatment
CAT#162308 BIOMET STEM LOT#277250
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