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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem Loss of Range of Motion (2032)
Event Type  Injury  
Manufacturer Narrative
Literature citation: christopher e.Gross, md et al.Surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty.Foot & ankle specialist.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, it was reported by gross et al in "surgical treatment of bony and soft-tissue impingement in total ankle arthroplasty" that in a retrospective study in which several implants from various manufacturers including inbone, it was found that 75 patients (7.5%) required either open (n = 49) or arthroscopic debridement for impingement after tar; 44 patients had >12 months of follow-up, with a follow-up of 26.5 months after their debridement procedure.The mean time to the debridement procedure for all prostheses was 9.3 months, with an average of 21.8 months with inbone.Of the patients with more than 1 year's follow-up from their debridement, 84.1% were asymptomatic; 9 patients (20.4%) had repeat operations after their debridement procedure.Of these, 5 patients required a repeat debridement of their medial or lateral gutters for a failure rate of 11.4%.
 
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Brand Name
INBONE TOTAL ANKLE SYSTEM
Type of Device
PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis, TN 38117
9014516318
MDR Report Key7893599
MDR Text Key120861066
Report Number1043534-2018-00137
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 literature
Reporter Occupation Other
Type of Report Initial
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Event Location Hospital
Initial Date Manufacturer Received 08/21/2018
Initial Date FDA Received09/20/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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