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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNKNOWN STEM; PROSTHESIS, HIP Back to Search Results
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Date 01/30/2024
Event Type  Injury  
Event Description
It was reported, a patient underwent a hip revision, due to metalosis.The head was removed and replaced.It was reported, that no further information is available.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00485, 0001825034-2024-00486.D10: unknown head, unknown cup.The device will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
 
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Brand Name
UNKNOWN STEM
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
p.o. box 587
warsaw IN 46581
Manufacturer Contact
jennifer rapsavage
56 e. bell dr.
warsaw, IN 46582
5745260384
MDR Report Key18749365
MDR Text Key335932636
Report Number0001825034-2024-00487
Device Sequence Number1
Product Code PBI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2024
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
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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