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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL TRAY

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DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL TRAY Back to Search Results
Catalog Number UNK ANKLE TIBIAL TRAY
Device Problems Loss of Osseointegration; Osseointegration Problem; Migration
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 " salvage of a failed depuy alvine total ankle prosthesis with agility lp custom stemmed tibia and talar components¿, written by thomas s. Roukis, dpm, phd, published in clinical podiatry med surg 30 (2013), 101-109, was reviewed. The article presents a case of revision of a phase 2 version of the depuy alvine total ankle prosthesis (depuy) to a custom-designed stemmed tibial and talar component agility lp total ankle replacement system (depuy). The patient sustained a left-sided pronation-abduction ankle fracture dislocation following a fall from a height and underwent open reduction with internal fixation in 1994. He developed distal-lateral tibial osteonecrosis and advanced degenerative joint disease that was debilitating. Following removal of the retained deep internal fixation, he underwent primary implantation of a size-3 depuy alvine total ankle prosthesis at age 56 years. The tibial component subsequently developed subsidence with anterior angulation, and the talar component developed subsidence with varus angulation. The radiograph showed extensive syndesmosis arthrodesis, aseptic osteolysis and gross loosening of the tibial and talar components, with severe subsidence of the tibial component into the distal tibial metaphysis and severe varus deformity of the hindfoot originating from the ankle. Clinical evaluation revealed severely restricted range of motion with an osseous end to both dorsiflexion and plantarflexion motion as well as lateral ankle instability emanating from the ankle and subtalar joint. He was initially treated with functional brace therapy and lateral insole wedging that failed to provide relief. Due to this, the patient had an agility lp custom-design stemmed tibial and talar component total ankle replacement with lateral ankle stabilization implanted. Except for some rebound peripheral edema once immobilization began, no complications occurred, and the patient progressed to return to full ambulation. After one-year follow-up, the patient remains pain free, has acceptable range of motion and is well aligned. This patient had two depuy implants and both will be addressed on this complaint.

 
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Brand NameUNKNOWN ANKLE TIBIAL TRAY
Type of DeviceANKLE TIBIAL TRAY
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
1210 ward avenue
west chester , PA 46581-0988
6107428552
MDR Report Key9468121
Report Number1818910-2019-121220
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ANKLE TIBIAL TRAY
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 Received01/08/2020
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: 12/13/2019 Patient Sequence Number: 1
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