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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.1818910 AGILITY LP TALAR SZ3 RT ANKLE IMPLANT

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DEPUY ORTHOPAEDICS, INC.1818910 AGILITY LP TALAR SZ3 RT ANKLE IMPLANT Back to Search Results
Catalog Number 140403000
Device Problems Loss of Osseointegration; Appropriate Term/Code Not Available
Event Date 06/27/2017
Event Type  Injury  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

The patient was revised to address subsidence and loosening of talar component at the implant to bone interface.

 
Manufacturer Narrative

The device associated with this report was not returned. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameAGILITY LP TALAR SZ3 RT
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC.1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw , IN 46581
5743725905
MDR Report Key6740233
Report Number1818910-2017-21711
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number140403000
Device LOT NumberC13BW1000
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 Received08/22/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/25/2017 Patient Sequence Number: 1
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