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

Model Number 1555-35-000

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Inflammation (1932); Pain (1994); Numbness (2415); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/30/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

On (b)(6) 2003, the patient underwent a primary left total ankle replacement.Depuy products were implanted along with two unknown manufacturer screws.There were no indicated intra-operative complications.On (b)(6) 2008, the patient underwent a left ankle poly revision/exchange and debridement to address poly wear, cysts, pain, numbness, inflammation, swelling, adhesions, and infection.The patient was treated with oral antibiotics leading up to the revision operation.There were no indicated intra-operative complications.Doi: (b)(6) 2003.Dor: (b)(6) 2008; left ankle.

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 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: 11365535
• MDR Text Key: 233059169
• Report Number: 1818910-2021-03630
• Device Sequence Number: 1
• Product Code: OYK
• UDI-Device Identifier: 10603295058755
• UDI-Public: 10603295058755
• 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: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1555-35-000
• Device Catalogue Number: 155535000
• Device Lot Number: W34BV1009
• 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: 53 YR