SMITH & NEPHEW, INC. UNKN SMF SHORT MODULAR FEM STEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number UNKN01100204 |
Device Problem
Corroded (1131)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 10/31/2018 |
Event Type
Injury
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Event Description
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On the literature article named "modular junction may be more problematic than bearing wear in metal-on-metal total hip arthroplasty", it was reported that, after a smf stem had been implanted on 1 patient, 1 revision surgery was performed due to adverse reaction to metal debris.During this surgery, blackened corroded debris was observed at the junction between the stem and the modular neck.The stem was not well fixed and was explanted without the need of extended femoral osteotomy.The bearings were changed to ceramic on ceramic.
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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 requested clinical medical information/documentation is not available.Without patient-specific surgical records and x-rays, further assessment of the reported events cannot be provided, and the root cause beyond those reported in the article cannot be concluded.The patient impact beyond the reported events cannot be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may 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.Some potential probable causes for this event could include damaged product, implant corrosion or wear.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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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