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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS 1818910 AGILITY LP TIBIAL INSERT SZ4 ANKLE IMPLANT

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DEPUY ORTHOPAEDICS 1818910 AGILITY LP TIBIAL INSERT SZ4 ANKLE IMPLANT Back to Search Results
Catalog Number 140434000
Device Problem Insufficient Information (3190)
Patient Problem Osteolysis (2377)
Event Date 03/02/2016
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. (b)(4). Depuy synthes has been informed that the lot number is not available. This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.

 
Event Description

Patient was revised to address osteolysis.

 
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Brand NameAGILITY LP TIBIAL INSERT SZ4
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key5493383
MDR Text Key40114116
Report Number1818910-2016-15116
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK053569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial
Report Date 03/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number140434000
Device LOT NumberUNKNOWN
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 Received03/02/2016
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 TREATMENT DATA
Date Received: 03/10/2016 Patient Sequence Number: 1
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