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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A HEAD PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN M2A HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Pain (1994); Local Reaction (2035); Unspecified Tissue Injury (4559)
Event Date 02/25/2019
Event Type  Injury  
Event Description
Initial right total hip arthroplasty performed. The patient was revised fourteen years later due to metallosis and loosening. All components were revised; however, no medical records have been provided for confirmation of findings.
 
Manufacturer Narrative
(b)(4). Concomitant products: item #: unknown; unknown stem ; lot #: 757770; item #: unknown ; unknown cup ; lot #:092110. Product has been received by zimmer biomet and the investigation is in process. 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 - 03099, 0001825034 - 2019 - 03092.
 
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Brand NameUNKNOWN M2A 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 Key14078581
MDR Text Key289057626
Report Number0001825034-2022-00872
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot Number222090
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
Date Manufacturer Received05/02/2022
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: 04/11/2022 Patient Sequence Number: 1
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