SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 4-RT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 1-10003-400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 07/26/2023 |
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, after a tka surgery had been performed on (b)(6) 2023, a revision surgery had to be performed on (b)(6) 2023 because the patient had pain immediately after implantation that did not subside.Current health status of patient is unknown.
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Event Description
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It was reported that, after a tka surgery had been performed on (b)(6) 2023, a revision surgery had to be performed on (b)(6) 2023 because the patient had pain immediately after implantation that did not subside.Current health status of patient is unknown.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production records 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 that pain can result from improper positioning, loosening or wear of components.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 products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.
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