Catalog Number 114917 |
Device Problems
Loose or Intermittent Connection (1371); Unstable (1667)
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Patient Problems
Failure of Implant (1924); Discomfort (2330)
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Event Date 09/14/2017 |
Event Type
Injury
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Event Description
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Revision surgery - due to the surgeon notifying the agent about the upcoming revision with discovery elbow.Patient presented to surgeon, 3 years after index procedure, complaining of discomfort and instability.Her humeral implant appeared to be loose, possibly subsequent to a traumatic event at an undisclosed time.The surgeon did not know exactly the cause based on discussions with the patient.During the revision surgery, the implant was completely loose and removed by hand once the hinge was disassembled.The ulnar component was intact.
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Manufacturer Narrative
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The reason for this revision surgery was the patient had discomfort and instability.The actual length of in-vivo patient service for this product is unknown since the original surgery date was not provided or could not be established.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.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.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.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint will be closed with the lot number unknown pending receipt of additional information.No further action is deemed necessary at this time.The following are undetermined items or issues for this complaint: the revision fate on the product feedback for is unconfirmed.There was no dticket submitted for the original surgery.This complaint is deemed to be non-product related.The complaint states the patient had looseness, pain and instability in the elbow,.This revision was necessary to correct the patient's condition.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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Manufacturer Narrative
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Corrected data: manufacturer narrative: the reason for this revision surgery was the patient had discomfort and instability.The actual length of in-vivo patient service for this product is unknown since the original surgery date was not provided or could not be established.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.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.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint will be closed with the lot number unknown pending receipt of additional information.No further action is deemed necessary at this time.The following are undetermined items or issues for this complaint: the revision fate on the product feedback form is unconfirmed.There was no dticket submitted for the original surgery.This complaint is deemed to be non-product related.The complaint states the patient had looseness, pain and instability in the elbow,.This revision was necessary to correct the patient's condition.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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Search Alerts/Recalls
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