The reason for this revision surgery was the head locking screw loosened and the shell came off the stem taper.The surgeon replaced the humeral socket shell, humeral stem and socket insert.The head and locking screw were not noted as replaced.It is unknown if the head was reused or a product from another manufacturer was implanted.The in-vivo length of patient service for the implant was 4.8 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 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, design criteria 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 as non-product related.The root cause for this event was the head locking screw loosened and the shell came off the stem taper.No information or explanation was offered that would define the nature of the cause for this event.The scope of this investigation is limited without having the explanted 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 since there are no indications of a product or process issue affecting implant safety or effectiveness.
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