Catalog Number UNK KNEE FEMORAL STEM |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 04/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The primary surgery was performed on (b)(6) 2007.It was reported that the revision surgery was performed on (b)(6) 2018 due to the loosening of femur side by replacing the stem, the block, and the insert, and keeping the tibial tray in the patient¿s knee joint.No further information was provided by the hospital.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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