MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AGILITY TIBIAL INSERT SZ 5; ANKLE IMPLANT

Catalog Number	155535000
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Der states that the surgeon cleaned up the ankle joint because patient had gout and put in a new insert.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Depuy considers the investigation closed at this time.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.

• Brand Name: AGILITY TIBIAL INSERT SZ 5
• Common Device Name: ANKLE IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 7016771
• Report Number: 1818910-2017-28651
• Device Sequence Number: 16439931
• Product Code: HSN
• UDI-Device Identifier: 10603295058755
• UDI-Public: 10603295058755
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K920802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 155535000
• Device Lot Number: AA6DJ1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 11/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR