TORNIER INC AFFINITI PEGGED GLENOID SZ 44; PROTHESIS, SHOULDER, HEMI-, HUMERAL METALLIC UNCEMENTED
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Catalog Number 0020061 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Limb Fracture (4518)
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Event Date 12/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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The reported event that one patient required revision surgery due to a periprosthetic fracture could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available by the uk registry.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. please note, that reports received from the uk registry are not published reports and therefore web link is not available.H3 other text : device disposition unknown.
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Event Description
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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between (b)(6) 2012 ¿ (b)(6) 2022.During the review of the report, it was identified that on (b)(6) 2020 a patient required revision surgery due to periprosthetic fracture, which was not previously reported to the manufacturer.Revision procedure type: single stage revision.
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Search Alerts/Recalls
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