ENCORE MEDICAL, L.P. SLIDING CORE, UHMPWE,6M (STERILE PACKAGED); PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED
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Model Number 400-140F |
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 07/19/2022 |
Event Type
Injury
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Event Description
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It was reported that a poly was revised due to an acute infection unrelated to the implant.There were no known comorbidities or patient non-compliance resulting in the acute infection.
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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 in a supplemental report.
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Event Description
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It was reported that a poly was revised due to an acute infection unrelated to the implant.There were no known comorbidities or patient non-compliance resulting in the acute infection.
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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.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.However, a statement in the event details leads to believe that this is not device related.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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