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
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/02/2020 |
Event Type
malfunction
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Event Description
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It was reported that an or3o dual mobility trial liner 40/52 was found broken.This was found during inspection.No case involved.
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Manufacturer Narrative
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Internal complaint reference (b)(4).Results of investigation: the device, intended use in treatment, was returned for evaluation.A visual inspection confirmed the inner circle of the or3o dual mobility trial liner 40/52 shows nicks.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.
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