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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Ossification (1428); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation, however films were supplied for review which shows a failure of the anterior tibia.The reason for the failure is unknown.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the surgeon reported that the patient had: lucency surrounding the tibial component in the pegs with subchondral cystic changes, progressed since 2016 radiograph.Subchondral cystic changes deep to the talar component, progressed since 2016.There is slight anterior subluxation of the talus in relation to the tibia which may be exaggerated due to slight plantar flexion of the ankle.There is no displacement of the radiolucent articulating piece.Heterotopic ossification posterior tibiotalar joint.No evidence of acute fracture.Mild to moderate subtalar joint degenerative changes.Degenerative changes at the distal tibiofibular joint and ghost tracks in the distal fibula.Small corticated fragments of adjacent to the medial malleolus from prior fracture, unchanged.Small plantar fascial spur and posterior calcaneal enthesophyte.No joint effusion.Mild circumferential soft tissue swelling.Findings concerning for progressive loosening of the tibial component and increased cystic change around the talar component.

Event Description

It was reported that the patient underwent a revision surgery.The surgeon opted to fuse the ankle in the revision with the use of femoral head allograft and fusion plates.

Manufacturer Narrative

The product was returned.Visual examination of the tibial tray and poly shows deformation which is consistent with removal during the revision surgery.There is no visible damage to the talar dome.Bone cement remnants are on the tibial tray and talar dome.Also, visual examination the porous surface of the talar dome and tibial tray/stem does exhibit a few areas of apparent bone/tissue attachment.Postoperative radiographic images and cat scans were provided.From review of the images it does appear that there are areas with less bone/implant interface around the tibial tray and talar dome.

• Brand Name: INFINITY®
• 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 road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 6797518
• MDR Text Key: 82792899
• Report Number: 1043534-2017-00085
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/31/2017
• Event Location: Home
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 99