SMITH & NEPHEW, INC. UNKN CPCS HIP INSTR; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/19/2008 |
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 right thr surgery, there was a calcar fracture.The measures taken to resolve this intraoperative complication are unknown.The patient's health status is not known.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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The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the national joint registry of the united kingdom.Per case details, no further information is available.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided for this complaint will be re-evaluated.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 and patient condition.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.We consider this investigation closed.
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