SMITH & NEPHEW, INC. UNKN REDAPT MONOBLOCK STEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 01/24/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Moriarty, p., vles, g., haddad, f., & konan, s.(2021).Early clinical and radiological outcomes of a new tapered fluted titanium monobloc revision stem in hip arthroplasty.Archives of orthopaedic and trauma surgery, 141(6), 1065-1071.Doi: https://doi.Org/10.1007/s00402-021-03778-3.
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Event Description
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It was reported that on literature review "early clinical and radiological outcomes of a new tapered fluted titanium monobloc revision stem in hip arthroplasty", 1 patient developed a periprosthetic joint infection while on chemotherapy after a revision surgery using a (tftm) stem.The event was treated with debridement, antibiotics and implant retention (dair).Patient outcome is unknown.No further information is 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, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text and are not related to the reported infection.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.However, the chemotherapy cannot be ruled out as a contributory factor to the infection.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.Possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.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.Internal complaint reference number: (b)(4).
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