SMITH & NEPHEW, INC. ANTHOLOGY SO TR NECK SZ 7-12; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71365707 |
Device Problems
Crack (1135); Flaked (1246); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that, the magnets of three (3) anthology so tr neck sz 7-12 were falling out of the necks.They are cracked apart and flacking off.As this was noticed upon cleaning and sterilization activities, there was not patient involvement.
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Manufacturer Narrative
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H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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 products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.These devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the devices 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 products involved, our investigation could not proceed.Should the devices 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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