TORNIER INC LATITUDE EV ULNAR STEM 75 MM MEDIUM RIGHT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
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Catalog Number 0030120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Inflammation (1932); Implant Pain (4561)
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Event Date 09/28/2023 |
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
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Event Description
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The patient experienced heightened pain during maximum flexion, accompanied by slightly elevated inflammatory markers.A ct scan revealed signs of infection around the tip of the ulnar prosthesis.Following a consultation, a spect ct scan was ordered for further assessment.The surgeon indicated that the infection is not directly linked to the implant but is associated with the initial surgery.
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Event Description
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The patient experienced heightened pain during maximum flexion, accompanied by slightly elevated inflammatory markers.A ct scan revealed signs of infection around the tip of the ulnar prosthesis.Following a consultation, a spect ct scan was ordered for further assessment.The surgeon indicated that the infection is not directly linked to the implant but is associated with the initial surgery.
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Manufacturer Narrative
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The reported event was not confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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