SMITH & NEPHEW, INC. ENGAGE POROUS FEMORAL SZ 5-LT MED; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 1-10003-510 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Arthralgia (2355)
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Event Date 10/20/2022 |
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 a uka surgery had been performed on an unspecified date, the patient complained of chronic pain.A revision surgery was performed on the (b)(6)2022 to treat this adverse event.The patient received a tka system in exchange.
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Manufacturer Narrative
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B3 (date of event), b5 (event description), d6a (date of implantat ion).
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Event Description
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It was reported that, after a uka surgery had been performed on the (b)(6) 2021, the patient complained of chronic pain.A revision surgery was performed on the (b)(6) 2022 to treat this adverse event.The patient received a tka system in exchange.No further information is available at the moment.
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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.The clinical/medical investigation concluded that per complaint details, a revision/conversion to total knee arthroplasty surgery was performed due to patient complaints of chronic pain.An electronic photo of a left unicompartmental knee arthroplasty charstiks sheet (dated (b)(6) 2021) and open surgical wound imaging (dated 10/20) were provided, which would likely indicate revision to be approximately 21 months post implantation; however, the photos do not provide insight into the clinical root cause of the reported event.Of note, the symptom onset date is unknown, and although the wound image date does not correlate with the reported occurrence date of 11/20/2022, this is believed to be only a typographical error in occurrence date (but no clarification has been received to date).Surgical details and if the components had bony integration or were loosened is unknown.The patient impact beyond the reported chronic pain and revision/conversion to total knee arthroplasty could not be determined.No further medical assessment could be rendered at this time.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 has been identified in adverse effects and complications.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 may be indicated.
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