Model Number PIP-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Implant Pain (4561)
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Event Date 11/29/2021 |
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 in a supplemental report.Device disposition unknown.
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Event Description
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It was reported that a revision took place due to pain and a possible infection.
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Event Description
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It was reported that a revision took place due to pain and a possible infection.
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Manufacturer Narrative
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Please note the correction to h3 reason for no evaluation and h6 method codes.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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.H3 other text : device discarded or lost.
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Search Alerts/Recalls
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