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

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.

• Brand Name: AGILITY TIBIAL SHELL SZ 3 RT
• Type of Device: ANKLE 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 Key: 5054020
• MDR Text Key: 24946561
• Report Number: 1818910-2015-29728
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: PK920802
• Number of Events Reported: 1
• 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 Received: 09/03/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/21/2009
• Device Catalogue Number: 155513000
• Device LOT Number: Y37BF1
• 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 Received: 08/31/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/21/2004
• 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