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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN TRABECULAR METAL ANKLE PROSTHESIS, ANKLE

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ZIMMER, INC. UNKNOWN TRABECULAR METAL ANKLE PROSTHESIS, ANKLE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may be necessary. Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.

 
Event Description

Patient has been indicated for an ankle arthroplasty revision procedure due to unknown reasons.

 
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Brand NameUNKNOWN TRABECULAR METAL ANKLE
Type of DevicePROSTHESIS, ANKLE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6347275
MDR Text Key67893214
Report Number0001822565-2017-01048
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 02/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 02/21/2017 Patient Sequence Number: 1
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