SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 71343200 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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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 a thr surgery, the oxinium femoral head 12/14 32mm +0t was found to be scratched.The procedure was resumed, without any delay, with a s+n back-up device of the same size.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.The visual inspection revealed scratches on the surface of the device.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.A review made by the quality engineering team revealed that multiple areas of obvious damage were noted on the articulating surface which broke the oxide layer, exposing raw material.This made determining the exact defect impossible.Because the complaint is aesthetic in nature, no measurements were needed in verification of product dimensions.According to the visual standard for oxinium head inspection scratches or abrasions that do not appear superficial are not acceptable.Due to current processes in place to detect such defects, and evidence that this lot in particular was inspected carefully enough to detect those defects at the final inspection operation, it is determined that the time and cause of the surface damage cannot be concluded to have occurred during the manufacturing process.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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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