MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AGILITY TIBIAL SHELL SZ 5 LT; AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL

Catalog Number 155525000

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

Usa 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 (b)(6) 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 SHELL SZ 5 LT
• 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: 11358413
• MDR Text Key: 233034728
• Report Number: 1818910-2021-03529
• Device Sequence Number: 1
• Product Code: OYK
• 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 Catalogue Number: 155525000
• Device Lot Number: W4AFL1002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: IN
• Patient Sequence Number: 1
• Treatment: AGILITY POST AUG TALAR SZ 5; AGILITY TIBIAL +2 INSERT SZ 5; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR