TORNIER INC PERFORM REV INSERT SZ 3/4 39MM DIA +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number DWP2390 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Range of Motion (2032); Discomfort (2330)
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Event Date 09/14/2023 |
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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In the phs stemless ide study, a participant reported stiffness and discomfort in the neck and left hand.Despite receiving treatments like meloxicam and oral steroids, the symptoms persisted.Seeking a second opinion from a hand specialist, the patient underwent a steroid injection in the left ring and long fingers.Dissatisfied with the progress and care, the participant was referred to another hand surgeon for further evaluation, including pending emg and cervical mri.The patient attributes the symptoms to a previous shoulder surgery, expressing certainty that it is the root cause.
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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.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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In the phs stemless ide study, a participant reported stiffness and discomfort in the neck and left hand.Despite receiving treatments like meloxicam and oral steroids, the symptoms persisted.Seeking a second opinion from a hand specialist, the patient underwent a steroid injection in the left ring and long fingers.Dissatisfied with the progress and care, the participant was referred to another hand surgeon for further evaluation, including pending emg and cervical mri.The patient attributes the symptoms to a previous shoulder surgery, expressing certainty that it is the root cause.
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