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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR

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DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR Back to Search Results
Catalog Number UNK ANKLE TALAR
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); No Code Available (3191)
Event Date 01/01/2013
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
 
Event Description
The literature article entitled ¿use of femoral locking plate for salvage of failed ankle arthroplasty after trauma¿ written by lawrence a. Didomenico, dpm, facfas, et al; published in the journal of foot and ankle surgery, in 2013, 52, 397-401; was reviewed. This article reports on a case study of a (b)(6) year old woman with a medical history of gout, cancer, heart disease, hypertension, foot and leg cramping, varicose veins and post-traumatic arthritis presented with a chief chronic complaint of ankle pain that had worsened during a six-month period. She related a vast history or fractures and recurrent sprains to her left ankle. Conservative measures were attempted for two years until she finally underwent a total ankle prosthesis, agility, lp total ankle system (depuy), gastrocnemius recession, and midfoot fusion. The patient experienced a stable, non-symptomatic pseudo-arthritis of the tibiofibular joint. This construct proved to be satisfactory for five years, until the patient fell down the steps. After the accident, radiographs revealed the talar component had been anteriorly displaced and rotated. The pseudo-arthritis demonstrated no changes, widening or instability; thus it was believed to be unrelated to the trauma. The patient also showed signs of tenderness and swelling of the left ankle. She was pain free with rom to the subtalar joint. An attempted revision proved to not be possible, and the total ankle arthroplasty was removed, and ankle fusion was performed using an anterior ankle arthrodesis locking plate (manufacturer not specified).
 
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Brand NameUNKNOWN ANKLE TALAR
Type of DeviceANKLE TALAR
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9428469
MDR Text Key185235835
Report Number1818910-2019-121636
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ANKLE TALAR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/06/2019 Patient Sequence Number: 1
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