Catalog Number DWJ401 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Muscle Weakness (1967); Loss of Range of Motion (2032); Hyperextension (4523)
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Event Date 03/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text: device disposition unknown.
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Event Description
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A phs stemless ide subject showed mild anterior impingement along the conjoin tendon, exacerbated by hyperextension and maximal forward flexion.Treatment involved a corticosteroid injection into the conjoin tendon.The issue's relatedness to the device was deemed possible, but it was considered unrelated to the surgery.
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Manufacturer Narrative
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Correction: d4 lot#: the reported event was not confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned 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.No indications of material, manufacturing or design related problems were found during the investigation.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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Event Description
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A phs stemless ide subject showed mild anterior impingement along the conjoin tendon, exacerbated by hyperextension and maximal forward flexion.Treatment involved a corticosteroid injection into the conjoin tendon.The issue's relatedness to the device was deemed possible, but it was considered unrelated to the surgery.
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Search Alerts/Recalls
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