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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems 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 01/09/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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 right total ankle replacement.Depuy products were implanted along with two unknown manufacturer screws.The surgeon indicated an intra-operative complication of nicking one of the veins in the neurovascular bundle, the nick was cauterized and then tied off with no indicated resulting patient, injury, harm, or resulting complication.The event occurred prior to the use of any depuy product.On (b)(6) 2019, the patient underwent a right ankle removal of total ankle components and placement of competitor nails and fusion of adjacent bones.All depuy products were removed.Prior to the procedure, the patient was experiencing the following adverse symptoms: pain, decreased range of motion, edema, difficulty walking, osteolysis, numbness, weakness, instability, cysts, stiffness, and loosening of the entire system.The surgeon also indicated removing two stripped screws (of unknown manufacturer).Doi: (b)(6) 2003.Dor: (b)(6) 2019; right 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 (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 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: 11365817
• MDR Text Key: 233079291
• Report Number: 1818910-2021-03638
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 10603295058755
• UDI-Public: 10603295058755
• Combination Product (y/n): N
• PMA/PMN Number: K920802
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1555-35-000
• Device Catalogue Number: 155535000
• Device Lot Number: XX2C51015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 04/09/2021
• Supplement Dates FDA 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 RT; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW; AGILITY POST AUG TALAR SZ 5; AGILITY TIBIAL SHELL SZ 5 RT; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR