SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
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Catalog Number UNKN01100102 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Deformity/ Disfigurement (2360); Ambulation Difficulties (2544)
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Event Date 11/04/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, after medically indicated revision of right total hip femoral component performed on (b)(6) 2013, where redapt mod slvd stem 300mm sz 18 was implanted, patient presented issues related to intoeing.On follow up performed on (b)(6) 2014, antalgic gait favoring left leg and intoeing were noted.It is unknown if or how the adverse events were treated.Patient outcome is unknown.Additional details about primary surgery are unknown.This de-identified clinical data is related to a post market clinical follow-up activity for redapt sleeved mono stems.As the data collection activity has been done retrospectively and data is provided anonymized, the information provided is limited and further information cannot be obtained.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per case details, after a revision of the right total hip femoral component was performed, the patient was noted to have antalgic gait favoring left leg and intoeing after follow-up at approximately 1 year.It has been reported that no additional information is available.No further patient specific clinically relevant information was provided for evaluation.It has been reported that no additional information is available.Without clinically relevant information for evaluation, the root cause of the reported symptoms cannot be definitively concluded.Further patient impact beyond the reported antalgic gait favoring left leg and intoeing could not be assessed.No further medical assessment could be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to traumatic injury, abnormal motion over time, bone degeneration, fit/sizing, patient anatomy or abnormal loading of limb.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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