Model Number N/A |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/22/2015 |
Event Type
Injury
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Event Description
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It was reported that a patient had a revision surgery due to loosening just over a year post-implantation.The head and stem were revised without complication.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).G2: foreign: germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024 -00062.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable as it was confirmed that the reported event was unrelated to the reported zb device.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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