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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. M2A-MAGNUM 42-50MM TPR INSRT-6 PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog number:us157852 lot number:213320 brand name: m2a-magnum pf cup, catalog number:157446 lot number: 368600 brand name:m2a-magnum mod hd, catalog number:139252 lot number:688380 brand name: m2a-magnum 42-50mm, catalog number:192413 lot number: 607420 brand name: echo por fmrl red. Multiple reports were submitted along with this report 0001825034-2022-00633, 0001825034-2022-00634 and 0001825034-2022-00635. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient was revised due to pain, effusion and metallosis approximately 10 years post implantation. Additional information on the reported event is unavailable.
 
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Brand NameM2A-MAGNUM 42-50MM 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 Key13860929
MDR Text Key287684726
Report Number0001825034-2022-00635
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,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
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 Number139252
Device Lot Number688380
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2010
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: 03/23/2022 Patient Sequence Number: 1
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