SMITH & NEPHEW, INC. UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number UNKN01000000 |
Device Problems
Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/30/2015 |
Event Type
Injury
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Event Description
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On the literature article named "ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population", it was reported that, after a opti-fix cup had been implanted on 1 patient, patient #4 of the study, a revision surgery was performed 7,7 years after the primary surgery due to wear and aseptic loosening.The opti-fix cup, opti-fix insert and femoral head were explanted.Patient outcome is unknown.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented in the aged article on the,¿ ten to fifteen-year clinical and radiographic follow-up with a third-generation cementless stem in a young patient population", did not provide insight or relevance to current clinical outcomes for the product/device.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; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.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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