WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY®; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33650005 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Osteopenia/ Osteoporosis (2651)
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Event Date 04/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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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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Allegedly, at an unknown time after the original total ankle surgery, patient returned to surgeon and revision total arthroplasty was prescribed.The surgeon noted that the tibia bone showed significant loss of density around the implant, with implant subsidence pointing to implant loosening.A different system was used in the revision surgery.Intra-op, the surgeon noted that both the tibia and talus had poor bone ongrowth and the bone quality had degraded.Four cultures, including one "deep ankle," were sent to the lab intra-op, but no infection was found.
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Search Alerts/Recalls
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