ENCORE MEDICAL L.P EMPOWR ACETABULAR, DUAL MOBILITY, METAL LINER, 44G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 951-01-44G |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
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Event Description
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It was reported there was a 25 minute delay in surgery.
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Manufacturer Narrative
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The agent reported (primary total hip tried using dual mobility could not get the liner to seat.Tried multiple times doctor said the taps were not lining up on the cup.) this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was not completed as intended and there was a thirty-five-minute delay.The implant was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.Rma examination: the implant was returned to djo and after further examination, only the metal liner was returned, issue could not be replicated with just the once piece, because of this no error could be determined.A review of 951-01-44g device history record (dhr) revealed the implant, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this implant.Complaint database review showed no previous complaints and there were no indications that this implant has a design or material deficiency.The root cause of this complaint is difficult to determine since the metal liner was the only device that was returned.Because of this no fault could be identified.This is not an event associated with a product failure, malfunction, or issue.
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