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

Model Number	1555-35-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Numbness (2415); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11365817
• Report Number: 1818910-2021-03638
• Device Sequence Number: 16431960
• Product Code: HSN
• UDI-Device Identifier: 10603295058755
• UDI-Public: 10603295058755
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K920802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1555-35-000
• Device Catalogue Number: 155535000
• Device Lot Number: XX2C51015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR