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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. AGILITY TIBIAL SHELL SZ 3 RT ANKLE IMPLANT

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DEPUY ORTHOPAEDICS, INC. AGILITY TIBIAL SHELL SZ 3 RT ANKLE IMPLANT Back to Search Results
Catalog Number 155513000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 08/17/2015
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

Patient was revised to address pain.

 
Manufacturer Narrative

No device associated with this report was received for examination. A complaint database search found one previous report on the agility tibial shell sz3 rt. Review of the device history records did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination. The investigation could not draw any conclusions regarding the reported event. Based on the inability to determine a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

 
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Brand NameAGILITY TIBIAL SHELL SZ 3 RT
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw, IN 46581
5743714918
MDR Report Key5054020
MDR Text Key24946561
Report Number1818910-2015-29728
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK920802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/21/2009
Device Catalogue Number155513000
Device LOT NumberY37BF1
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 Received08/31/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/21/2004
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: 09/03/2015 Patient Sequence Number: 1
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