The reason for this revision surgery was the poly bearing was worn, the bearing and condyles were replaced.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could be established.The complaint was noted the primary most likely occurred approximately 10 years ago.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 record (dhr) was not conducted since a lot number was not provided or determined during the complaint evaluation.The implant in-vivo service length is unknown without an original surgery date.Multiple searches of the djo surgical records by surgeon and patient database revealed no additional information concerning this event.No additional information was obtained from the agent to assist in the event identification and evaluation.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint is deemed to be non-product related.The complaint states the patient had a worn poly bearing in the elbow.The surgeon reported no issues associated with the explanted product.The complaint investigation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.No other conditions relating to this event could 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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