Model Number 1365-32-320 |
Device Problem
Naturally Worn (2988)
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Patient Problem
No Code Available (3191)
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Event Date 03/03/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that the patient being revised for suspected loosening of +4/10 degree altrx liner.It was confirmed that the liner was grossly loose and all of the "tabs" of the liner had been worn off.The ceramic head had worn through the hood of the liner and was articulating on the edge of the pinnacle cup.Surgeon believes that the patient's high bmi (40) contributed to the event.At the time of the primary, even with substantial cup version, he felt it necessary to implant a 10 degree face changing liner.He believes this was a mistake and that the patient was levering off her soft tissues.We exchanged her liner for a standard +4 neutral liner and a longer head.No further patient information available.Doi: (b)(6) 2018.Dor: (b)(6) 2020; right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
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Search Alerts/Recalls
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