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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Manufacturer Narrative

Literature citation: gross et al.Outcomes of bone grafting of bone cysts after total ankle arthroplasty.Foot & ankle international.2016; vol 37: 157-164.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 in an article by gross et al titled "outcomes of bone grafting of bone cysts after total ankle arthroplasty" that a retrospective study of 726 primary tars was performed.Eight patients underwent revision surgery due to cyst formations.Three of these patients had loosened talar prosthesis due to the cyst.Of those 3 patients, 2 had good bone ingrowth anteriorly but not posteriorly or around the stem.Three patients had failures that were observed after cyst grafting resulting in 3 revisions of both the tibial and talar implant (to inbone x 2, to infinity).One patient required a revision tibial inbone component after tibial implant loosening due to a cyst.Two years later, this patient needed a revision to inbone ii talus as a result of loosening of the prosthesis due to a recurrence of the cyst.

• 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 Key: 7894689
• MDR Text Key: 120894926
• Report Number: 1043534-2018-00142
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/20/2018
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR