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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 Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Malposition of Device (2616); Unintended Movement (3026); Migration (4003)
Patient Problems Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Event Date 01/01/2016
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. Investigation summary. No device was received. Root cause undetermined. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. (b)(4).

 
Event Description

The literature article entitled "short term results of the mobility total ankle system: clinical and radiographic outcome¿ written by yvonne r. A. Kerkhoff, et al; published in foot and ankle surgery, 22 pp 152-157 in 2016; was reviewed. The aim of the study was to determine the short-term results of the mobility total ankle system. More specific, short term results included the frequency of complications, reoperations and failure, the survival rate, patient reported outcomes and the prosthesis alignment. The article reports on 67 ankles (63 ankles followed up clinically) that were followed short-term radiographically after having a total ankle arthroplasty using the mobility total ankle system (depuy) between march 2008 and september 2013. Outcomes were assessed using patient reported outcomes, clinical evaluations and radiographic findings. There were two intraoperative complications that occurred. One was a fracture of the medial malleolus and one was a laceration of the flexor digitorum longus. Both cases were repaired intraoperatively and no problems were reported during follow-up. There were postoperative complications, excluding failures in 13 patients. Conservative treatment was sufficient for six of these and seven required a second operation. There was one deep infection which required operative debridement and polyethylene insert exchange within two months after the initial surgery. There was one case of subsidence of the talus component which required a subtalar arthrodesis with a bone graft in order to stabilize the component. There was also a case of a cyst located in the tibiofibular joint, which was treated with operative debridement and a bone graft. In four ankles, reoperation was necessary due to a painful impingement of the medial and/or lateral gutter. The time between surgery and the occurrence of complication was 1-29 months. Failure is defined as exchange of the tibial and/or talar components, occurred in three ankles. One patient had an early deep infection with a loose tibia component, which was treated with a two-stage revision of the tibia component. The two other patients continued their treatment in another hospital where one patient was treated with chronic ankle pain with an unknown cause and underwent amputation of the lower leg and the other patient had the prosthesis removed and ankle arthrodesis was conducted because of chronic pain and possible aseptic loosening. Radiographically, there was also four cases of malalignment observed of the tibial components and also five cases of talar malalignment.

 
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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
1210 ward avenue
west chester, IN 46581-0988
6103142063
MDR Report Key9427992
MDR Text Key185265203
Report Number1818910-2019-121608
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/15/2019
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 HEALTH PROFESSIONAL
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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