SMITH & NEPHEW, INC. ENGAGE POROUS TIBIAL TRAY SZ 3-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 1-10012-300 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Failure of Implant (1924); Pain (1994); Inadequate Osseointegration (2646)
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Event Date 02/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that after unicompartmental knee arthroplasty (uka) of an engage system had been performed, the patient experienced excessive pain.This adverse event was treated with a revision surgery conducted on (b)(6) 2023.During the surgery it was noticed that the femoral component was loose with zero bone ingrowth, the tibial component had minimal bone ingrowth and pathological stress shielding around the anchor, and there was significant poly wear.The current health status of the patient is unknown.
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Manufacturer Narrative
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The associated device was returned and evaluated.The visual inspection revealed did not reveal the stated failure mode.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The definitive clinical root cause and patient outcome and/or impact beyond that which has been reported in the complaint cannot be confirmed nor concluded.A review of the production record 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 similar previous events, however, no commonalities that would suggest a device deficiency were found.A review of the instructions for use documents for engage partial knee system revealed in the adverse effects and complications section that loosening or wear of one or more of the prosthetic components is often related to the risk factors identified in this document.Loosening can also occur as a result of an incorrect fixation or positioning of the components and pain as a result of improper positioning, loosening or wear of the components.Also, damaged fixation or implant loosening may happen as a result of bone resorption.There is not enough data available to conclude that the overall clinical benefit outweighs the potential risk profile when compared to the state of the art.The existing data identifies a potential signal that the performance is an outlier vs the state of the art with respect to the risk for revision.In addition, a historical review concluded that no previous escalated actions for this type of issue were identified.However, as a correction action a voluntary market removal will be performed for the engage cementless partial knee system due recent complaint data that indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries.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 abnormal motion over time, bone degeneration, size selected, lack of ingrowth, osteolysis and/or traumatic injury.Based on this investigation, the need for corrective action may be indicated.
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Event Description
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It was reported that after a left engage unicompartmental knee arthroplasty (uka) was performed in (b)(6) 2022, the patient experienced excessive pain, even after attending therapy.This adverse event was treated with a revision surgery conducted on (b)(6) 2023.During the surgery it was noticed that the femoral component was loose with zero bone ingrowth, the tibial component had minimal bone ingrowth and pathological stress shielding around the anchor, and there was significant poly wear.The patient reported to have a great recovery.
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Manufacturer Narrative
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B5 (event description).D4 (lot number).
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Search Alerts/Recalls
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