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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PLATE PROSTHESIS FOOT

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ZIMMER BIOMET, INC. UNKNOWN PLATE PROSTHESIS FOOT Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient's implant subsided. The components were used for sphenoid osteotomy of the foot bone. Attempts have been made and there is no further information at this time.
 
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Brand NameUNKNOWN PLATE
Type of DevicePROSTHESIS FOOT
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 Key12541552
MDR Text Key273647723
Report Number0001825034-2021-02736
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2021
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: 09/28/2021 Patient Sequence Number: 1
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