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Model Number 508-32-104 |
Device Problems
Break (1069); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)
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Patient Problem
Pain (1994)
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Event Date 05/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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The reason for this revision surgery was reported as pain from broken center screw.The previous surgery and the surgery detailed in this event occurred 1 year apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain from broken center screw.There were no findings during this evaluation that indicate the reported devices were defective.No other information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
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Event Description
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Revision surgery - patient presented to surgeon with pain associated with movement in his left shoulder.Patient claimed to be lifting something heavy when they heard and felt a snap in his shoulder.The surgeon performed a number of movement test and x-rayed the left shoulder.The x-ray showed the baseplate and glenosphere were askew from original placement and the central screw of the baseplate (508-32-104) had broken approximately mid-shaft.The peripheral locking screws remained intact and unbroken.The surgeon performed a surgical revision of the left shoulder, explanting all implants inventoried above.A femoral allograph was used to fill the void in the glenoid and a new baseplate, glenosphere, polyethylene liner and locking screws were implanted.Inventoried on dt 1012425.
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Search Alerts/Recalls
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