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Model Number 521-01-150 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Rupture (2208)
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Event Date 07/25/2018 |
Event Type
Injury
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Event Description
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Third revision surgery - due to the patient having pain and a subscapular rupture.The pain plan was to remove the neck, head, and glenoid and revise to a reverse total shoulder.
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Manufacturer Narrative
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(b)(4).Manufacturer narrative: the reason for this revision surgery was due to instability and a subscapular rupture.The previous revision surgery and the revision surgery detailed in this investigation occurred 7.8 months apart.The in vivo time for the implanted device is 1.5 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 implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of use during the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to instability and subscapular rupture.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.Inventory containment is not required as 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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Third revision surgery - due to the patient having instability and a subscapular rupture.The pain plan was to remove the neck, head, and glenoid and revise to a reverse total shoulder.
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Search Alerts/Recalls
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