WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM, TIBIAL, MID SIZE, 14 MM, RIGHT & LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 200010901 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention and the aftercare.Instruments or implants may become contaminated or flaws in decontamination can occur.This may lead to unsterile instruments or implants.These should not be used.If it goes unnoticed, the use of these devices may cause infection.Although ct scans were provided, the quality of the scans and lack of information did not allow for any assessment to be made.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 was not possible because the lot number was not communicated.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.Device disposition unknown.
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Event Description
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It was reported that the patient had an infection and underwent a procedure to remove the implant.No additional information is available at this time.
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Search Alerts/Recalls
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