WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Edema (1820); Pain (1994); Swelling (2091)
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Event Date 02/23/2017 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.Part # 33630022, lot 1581431; part # 33650002, lot 1583031; part # 33652206, lot 1541546.Part # 33630022, lot 1581431 is 09/28/2016; part # 33650002, lot 1583031 is 09/26/2016; part # 33652206, lot 1541546 is 05/01/2014.Eval: varus failure.Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
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Event Description
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It was reported that 2 months prior to total ankle replacement surgery, the patient had increased ankle pain.The patient had remote history of right ankle fractures.After conservative treatment failed, the patient underwent surgery.A few weeks after surgery, it was noticed that the ankle had increased swelling and edema.Two months post-op, varus fail of implant and a medial mal fracture were noted on films.The dpm called it a stress riser medial mal fracture.Three months post-op, the patient underwent an orif to treat the medial mal fracture.The dpm suggested on op notes that the fracture was a result from rom with physical therapy.
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Manufacturer Narrative
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The products were not returned; therefore, product analysis cannot be performed.Radiographic images from before the initial total ankle surgery and postoperative images after the medical intervention for the orif were provided.The images show an infinity total ankle, a screw through the medial malleolus into the tibia, and a plate with screws along the tibia.Without images taken immediately postoperative from the initial total ankle surgery and/or progressive image taken since the initial surgery, it is difficult to draw conclusions related to position.
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