SMITH & NEPHEW, INC. OR3O DUAL MOBILITY TRIAL LINER 40/52; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 71353303 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/22/2020 |
Event Type
malfunction
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Event Description
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It was reported that, during a thr procedure, the liner cracked while outside of the patient.Surgery was not delayed as a back up device was readily available.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device is fractured and the fractured pieces were returned, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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