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Catalog Number 426-12-100 |
Device Problems
Fracture (1260); Device Slipped (1584)
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Patient Problem
No Code Available (3191)
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Event Date 01/15/2015 |
Event Type
Injury
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Event Description
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Revision surgery - due to the femur having a fracture and the stem subsiding.The surgeon replaced the stem an sleeve.
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Manufacturer Narrative
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The reason for this revision surgery was the hip stem subsiding.The implant was in the patient for about two days prior to revision.No information is available about patient bone condition, operating procedure, or other factors that could have contributed to the above event.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records showed no non-conforming material reports associated with this product.A review of the product complaint report history showed no prior complaints against the part.The root cause for the subsided hip stem was most likely due to the periprosthetic or fractured bone around the stem.Periprosthetic fractures can be a result of poor bone quality, over-lateralizing the broach, excessive impaction force and/or depth or intra-operative fracture.There are no indications of a product or process issue affecting implant safety or effectiveness.
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Manufacturer Narrative
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Corrected data: corrected concomitant part and lot number.This was corrected as an amendment to pc-2015-00038.Amendment 18477 was created to correct the part and lot number for the concomitant.
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Search Alerts/Recalls
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