SMITH & NEPHEW, INC. OR3O DUAL MOBILITY TRIAL LINER 38/50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 71353302 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that during a thr, the or3o dual mobility trial liner 38/50 broke outside the patient.No pieces fell inside.There was no delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.The manufacturing process of the device did not contribute to the reported event.A visual inspection of the returned device confirmed the stated failure mode.The or3o dual mobility trial liner 38/50 is broken rendering device inoperative.The device shows excessive wear and tear.A review of complaint history did not reveal similar events for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.
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