Catalog Number 999805360 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2011 |
Event Type
Injury
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Event Description
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Litigation and medical records received.Litigation alleges pain and cyst formation.After review of medical records, the patient was revised due to failed left hip resurfacing.Operative notes indicated that here was some metallosis.There was a break at the bases of the femoral component.There was a very large cyst involving all of the greater trochanter.There was a hole through the anterior superior region of the greater trochanter though the cortex, however, the main cortex was intact.Doi: (b)(6) 2007.Dor: (b)(6) 2011; left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.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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Manufacturer Narrative
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Product complaint (b)(4).Mfr# is being retracted, since it was found to be a duplicate of mfr# 1818910-2021-25775.1818910-2021-25775 will be kept for investigation purposes.
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Search Alerts/Recalls
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