TORNIER S.A.S. AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number DWD181 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nerve Damage (1979); Pain (1994)
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Event Date 03/22/2019 |
Event Type
Injury
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Event Description
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It was reported that the patient had ulnar nerve tunnel syndrome and severe pain post-operative.
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Manufacturer Narrative
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This part is not approved for use in the united states; however a like device catalog # dwd181, 510k # k081059 was cleared in the united states.The reported event could not be confirmed since the involved devices were 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.A review of the device history was not possible because the lot number was not communicated.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.
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Event Description
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It was reported that the patient had ulnar nerve tunnel syndrome and severe pain post-operative.
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Manufacturer Narrative
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The reported event could not be confirmed since the involved devices were not returned for evaluation and no other evidences were provided.The root cause could not be determined specifically.The medical opinion of a medical expert states that "the fact that the patient developed the ulnar neuropathy four days after surgery, makes it plausible that it was caused by direct pressure on the ulnar nerve by the internal-rotation orthosis, that the patient was wearing after surgery".However, more information is required to determine an exact root cause.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.
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