Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Injury (2348); No Code Available (3191)
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Event Date 01/01/1998 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.
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Event Description
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The manufacturer became aware of a study from mayo clinic, rochester, minnesota, which was published in may 2010.The title of this report is ¿failure of metal radial head replacement¿ which is associated with the stryker rhead & rhead recon system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1998 and 2008.A review of the complaint handling database revealed that the events have not been previously reported by the hospital or by the author of the publication, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision due to failure of radial head prosthesis.18 out of 18 cases.
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Manufacturer Narrative
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New information in section h6 (patient code).
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Event Description
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The manufacturer became aware of a study from mayo clinic, (b)(6) minnesota, which was published in (b)(6) 2010.The title of this report is ¿failure of metal radial head replacement¿ which is associated with the stryker rhead & rhead recon system.Within that publication, postoperative complications/ adverse events were reported which occurred between 1998 and 2008.A review of the complaint handling database revealed that the events have not been previously reported by the hospital or by the author of the publication, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses revision due to failure of radial head prosthesis.18 out of 18 cases.
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Search Alerts/Recalls
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