SMITH & NEPHEW, INC. UNKN CPCS HIP INSTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number UNKOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hip Fracture (2349)
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Event Date 10/04/2019 |
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, during a tha surgery, the patient suffered a intraoperative trochanteric fracture.It is unknown if any s+n implant or instrument caused or contributed to this adverse event.It is also unknown how it was treated.It is unknown if this incident caused a surgery delay.Current health status of patient is unknown.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent either a revision or re-revision surgery where a polarcup shell was part of the hip construct.As such, no further information will be available.
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Manufacturer Narrative
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Section a2 and h6 (impact code) were updated.Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this reported event was derived from the national joint registry uk summary report for polarcup as part of a retrospective data collection.As such, no further information will be available.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was reported could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).
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