MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 AGILITY TIBIAL INSERT SZ 3; AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL

Model Number 1555-33-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Osteolysis (2377); No Code Available (3191)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 osteolysis around tibia and talar components.Original surgery was done around 10 years ago, no specific date given.The surgeon used bone graft and calcium phosphate to fill voids.Poly exchange.No surgical delay.Doi: (b)(6) 2010, dor: (b)(6) 2020, left ankle.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: AGILITY TIBIAL INSERT SZ 3
• Type of Device: AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10483100
• MDR Text Key: 205308992
• Report Number: 1818910-2020-19276
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10603295058694
• UDI-Public: 10603295058694
• Combination Product (y/n): N
• PMA/PMN Number: K020541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1555-33-000
• Device Catalogue Number: 155533000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 76