ASCENSION ORTHOPEDICS, INC. REVERSE BODY LRG; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
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Catalog Number BOD096008LRG |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, during a reverse total shoulder surgery, a morse taper disengaged from a reverse body lrg, therefore a glenoid body and stem dissociated.At which point both implants were extracted.The implants were attempted to be re-mated but the morse taper again did not hold.The implants were explanted.Surgery was resumed, after a non-significant delay, with smith and nephew back-up devices.
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Manufacturer Narrative
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H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the reverse body lrg.Therefore, no investigation is deemed for the other device.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that clinical documentation had not been received; therefore there were no clinical factors found which would have definitively contributed to the event.The current patient status is unknown.Patient impact beyond the disengaged morse taper/dissociated stem with component extraction, use of back-up components and the surgical delay cannot be determined.No further medical assessment can be rendered at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for titan¿ total shoulder system and titan¿ reverse shoulder system revealed that loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, and/or excessive activity.This has been identified as an adverse event.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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