ENCORE MEDICAL, L.P. KERAMOS, CERAMIC/CERAMIC HIP; OBSOLETE: FLARED RIM SHELL FOR CERAMIC INSERT, 52MM
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Catalog Number 498-00-052 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Code Available (3191)
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Event Date 09/15/2016 |
Event Type
Injury
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Event Description
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Revision surgery - the patient had a right total hip arthroplasty on (b)(6) 2001.It was a keramos-ceramic on ceramic hip implant.Due to the acetabular cup having become loose; the ceramic liner, acetabular shell, and screw were all removed, as well as the ceramic femoral head.The surgeon replaced the acetabular components with zimmer products and put in a new djo surgical cocr femoral head.
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Manufacturer Narrative
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(b)(4).The reason for this revision surgery was the patient had an acetabular cup that had become loose.The in-vivo length of service for the patient's implant was 14.4 years.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.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 (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed to be non-product related.The root cause for the looseness was not reported.The scope of this investigation is limited without having the parts available to djo surgical for evaluation.Other conditions, root cause, relating to this event could not be determined with confidence.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
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