WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 3 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 33650003 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Post Operative Wound Infection (2446); Fluid Discharge (2686)
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Event Date 09/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.H3 other text : device remains implanted in patient.
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Event Description
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It was reported that the patient's initial total ankle replacement was completed on 10/4/2019 and patient was compliant following this procedure.On 11/15/2019, patient did return for a follow-up appointment and reported draining.Surgeon had concern of a superficial skin infection, but did not see signs of a deep infection of the ankle joint.Patient was treated for the superficial skin infection and did subsequently have a superficial irrigation and debridement.At the 5 month follow-up appointment on 12/5/2019, the patient had been admitted to the hospital for a severe case of diverticulitis and required a partial cheilectomy.Patient was very pleased with the progress at this point.
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Event Description
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It was reported that the patient's initial total ankle replacement was completed on (b)(6) 2019 and patient was compliant following this procedure.On (b)(6) 2019, patient did return for a follow-up appointment and reported draining.Surgeon had concern of a superficial skin infection, but did not see signs of a deep infection of the ankle joint.Patient was treated for the superficial skin infection and did subsequently have a superficial irrigation and debridement.At the 5 month follow-up appointment on (b)(6) 2019, the patient had been admitted to the hospital for a severe case of diverticulitis and required a partial cholectomy.Patient was very pleased with the progress at this point.
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Manufacturer Narrative
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The reported event could not be confirmed for infection due to the lack of additional clinical information.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿the tibial component is severely displaced anteriorly and luxated with some large cysts adjacent to the prosthesis.A periprosthetic fracture is not visible, though.Loosening and migration can be confirmed for the tibial component.The pe cannot be assessed directly.There is no indirect sign of loosening or breakage, though.The talar component shows radiolucence and adjacent to the central part of the talar implant there is a very large cyst visible, which is destabilizing the foundation of the implant.This indicates loosening and subsidence.Infection cannot be assessed with the ct scan only.There is no information given, that any infection is present.There was a superficial infection treated shortly after the implantation 2019.There is no further information on any infection now.¿ this complaint record captures the reported superficial wound infection that occurred shortly after implantation.The revision was due to loosening and migration of the tibial and talar components which were captured under a previous complaint record.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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