TORNIER INC PERFORM HUMERAL STEM SZ 3 PLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER + ADDITIVE, CEMENTED
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Model Number DWX3PS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930)
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Event Date 12/30/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient had an infection and small stitch abscess.
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Manufacturer Narrative
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Device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
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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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It was reported that a patient had an infection and small stitch abscess.
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Search Alerts/Recalls
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