MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AGILITY TIBIAL +2 INSERT SZ 5; AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL

Model Number 1555-35-020

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

Patient Problems Cyst(s) (1800); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Numbness (2415); Ambulation Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 11/14/2018

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

Medical records were received on (b)(6) 2021.Doi: unknown, dor: unknown, unknown affected side.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since 01-jan-2015.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: AGILITY TIBIAL +2 INSERT SZ 5
• Type of Device: AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11358408
• MDR Text Key: 232824532
• Report Number: 1818910-2021-03530
• Device Sequence Number: 1
• Product Code: OYK
• UDI-Device Identifier: 10603295058779
• UDI-Public: 10603295058779
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1555-35-020
• Device Catalogue Number: 155535020
• Device Lot Number: X5EJ51
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AGILITY POST AUG TALAR SZ 5; AGILITY TIBIAL SHELL SZ 5 LT; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW; AGILITY POST AUG TALAR SZ 5; AGILITY TIBIAL SHELL SZ 5 LT; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR