ENCORE MEDICAL L.P. X-ALT HIP; LINER, ACETABULAR, 20 DH, HXL/FMP, 36MM ID 56MM CUP OD, MP9
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Model Number 933-36-256 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 09/12/2017 |
Event Type
Injury
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Event Description
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Revision surgery - due to the patient having significant metallosis and pain.
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Manufacturer Narrative
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The reason for this revision surgery was the patient was having significant metalosis and pain.The in-vivo length of patient service for the implant was 3.9 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.There are no reported pre-existing patient health conditions.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 not released by the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.The device was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.This event is deemed to be non-product related.The root cause of this complaint was a revision surgery due to the metallosis and pain.There are multiple factors that may contribute to the event that are outside the control of djo surgical are increased toxic levels in the body, patient behavior and activities or trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.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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