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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL INSERT Back to Search Results
Catalog Number UNK ANKLE TIBIAL INSERT
Device Problem Fracture
Event Type  Injury  
Manufacturer Narrative

Product complaint (b)(4). (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 purpose of the article was to provide a comprehensive review of various complications associated with taa, with a literature review and summation of the previously reported data. This was compared with survivorship and complication rates at the authors¿ unit. In this unit, 278 taa¿s performed by four foot and ankle surgeons over a period of six years (2008-2013) were reviewed. These included 184 mobility ankle systems, depuy; the remaining were competitor implants. Depuy products used: the mobility total ankle system which includes a cobalt-chrome tibial component, a uhmwpe bearing insert and a cobalt-chrome talar component. The adverse events that occurred are as follows: six had deep infection; 27 had medial malleolar fractures; four had lateral malleolar fractures; 20 had superficial infections; delayed wound healing in nine; medial gutter pain in 31 patient with the majority of these happening with mobility implants; 16 had aseptic loosening and osteolysis; seven ankles were revised due to edge-loading; one ankle experienced a polyethylene component fracture; and a venous thromboembolism occurred in two ankles.

 
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Brand NameUNKNOWN ANKLE TIBIAL INSERT
Type of DeviceANKLE TIBIAL INSERT
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
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9545882
Report Number1818910-2020-00327
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ANKLE TIBIAL INSERT
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 Received02/12/2020
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: 01/03/2020 Patient Sequence Number: 1
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