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Catalog Number 508-32-104 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Date 09/24/2015 |
Event Type
Injury
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Event Description
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Revision surgery - the patient claims he did not fall, but the baseplate somehow moved causing a revision to be completed.
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Manufacturer Narrative
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The reason for this revision surgery was due to the baseplate moving.The length of in vivo service was 2.4 years.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 (b)(4) for examination.A review of the device history records showed no non-conforming material reports associated with the main contributor component listed in the complaint.A review of the product complaint report history showed there have been (b)(4) prior complaints reported against this part number; summary of investigations: 36 for trauma, 36 for looseness and stability,19 for infection,19 for dislocation and others not associated with product issues.This is the first complaint against this lot number.The surgeon reported no issues associated with the product and provided no information that definitively described the root cause or reason of the movement of the baseplate.A possible fall by the patient may have been a contributory factor.No other conditions relating to this event could be determined with confidence.There are no indications of a product or process issue affecting implant safety or effectiveness.
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Search Alerts/Recalls
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