On (b)(6), 2010 an agent reported a revision surgery.
The doctor suggested the reason for the surgery may be due to possible metallosis.
The original surgery was performed on or about (b)(6), 2010 meaning the components had been implanted approximately 2.
5 years at the time of the revision.
The outcomes attributed to the event are required intervention to prevent permanent impairment/damage.
There was no delay in surgery and another suitable device was available for use.
The revision surgery was completed as intended.
The device was not returned to djo surgical for examination.
A review of the device history records showed no non-conforming material reports associated with this product.
All released components met critical dimensions and specifications.
A review of the product complaint report history shows there are 19 prior complaints against the part number 499-38-009 metal-on-metal liner.
This is the first complaint of metallosis for this part number and the first complaint for this lot number.
The complaints include: four involving infection, three for osteolysis and general pain, two for dislocation issues, two for liner displacement, one for a squeaky hip, one loose stem, one metal hypersensitivity, one liner wear, and one for trauma.
The root cause for the revision surgery is listed as possible metallosis.
Because the components were not returned, a definitive root cause cannot be determined.
Metallosis is a complication of total joint replacement that triggering an adverse reaction in the surrounding tissue and is caused by metal wear which introduces loose metal material into the joint area.
All components have been shown to have met all critical specifications when released from djo surgical and there has been no evidence presented that suggests a product design or manufacturing problem contributed to the revision.
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