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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US AGILITY TIBIAL INSERT SZ 5 AGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL Back to Search Results
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.
 
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Brand NameAGILITY TIBIAL INSERT SZ 5
Type of DeviceAGILITY ANKLE SYSTEM IMPLANT : ANKLE TIBIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr
warsaw, IN 46581
6107428552
MDR Report Key11365817
MDR Text Key233079291
Report Number1818910-2021-03638
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K920802
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
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 Received02/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1555-35-000
Device Catalogue Number155535000
Device Lot NumberXX2C51015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/12/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2021 Patient Sequence Number: 1
Treatment
AGILITY POST AUG TALAR SZ 5; AGILITY TIBIAL SHELL SZ 5 RT; UNK MANUFACTURER SCREW; UNK MANUFACTURER SCREW
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