WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, BASE SIZE, 18 MM, RIGHT & LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 200009902 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Migration (4003)
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Patient Problems
Failure of Implant (1924); Implant Pain (4561)
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Event Date 10/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient.Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that the patient underwent a total ankle replacement.The patient complained of pain.Allegedly, the patient may need to undergo a revision surgery for implant loosening likely caused by patient anatomy.
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Manufacturer Narrative
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The complaint could be confirmed, since the information for evaluation matches the alleged failure.Medical profession reviewed the received information and noted: left ankle joint, inbone tar in situ.The tibial component consists of the described components: - inbone tibial top stem, inbone tibial base stem, and inbone tibial tray left.All components are intact and there are no signs of component dissociation.The component is surrounded by a radiolucent line, suspect of loosening.There are cystic changes in the adjacent tibial bone.The - inbone poly sz4+ 10mm sulcus looks intact, as far as can be assessed on a ct-scan.The talar component, consisting of inbone talar dome sz4 sulcus, and inbone talar stem are intact without signs of component dissociation.The component has subsided laterally and is surround by significant degenerative bone changes (cysts) in the talus.There are degenerative changes in the adjacent subtalar and talonavicular joints.Whether these are symptomatic cannot be assessed without clinical information.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.Based on investigation, the root cause was attributed to a patient factors issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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Event Description
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It was reported that the patient underwent a total ankle replacement.The patient complained of pain.Allegedly, the patient may need to undergo a revision surgery for implant loosening likely caused by patient anatomy.
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