WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 33680014 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Swelling/ Edema (4577)
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Event Date 05/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided on a supplemental report.
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Event Description
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It was reported that the patient presented to the clinic on (b)(6) 2022, concerned about an infection of the anterior ankle incision.The physician noted a surgical wound complicated by dehiscence, drainage of purulent fluid, swelling, and erythema.Following a right ankle wound irrigation and debridement on (b)(6) 2022, the physician noted no evidence of a deep infection.Routine culture final report on (b)(6) 2022, confirmed a staphylococcus aureus infection.Patient was prescribed keflex.
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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.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 more information is provided, the case will be reassessed.
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Event Description
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It was reported that the patient presented to the clinic on (b)(6) 2022, concerned about an infection of the anterior ankle incision.The physician noted a surgical wound complicated by dehiscence, drainage of purulent fluid, swelling, and erythema.Following a right ankle wound irrigation and debridement on (b)(6) 2022, the physician noted no evidence of a deep infection.Routine culture final report on (b)(6) 2022, confirmed a staphylococcus aureus infection.Patient was prescribed keflex.
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