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Catalog Number 254500692 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The size 9/10 5mm shim is cracked.The size 6mm was missing the silver ring in the hole where it attaches to the insert.
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Examination of the returned device confirms the reported event of trial damage/missing component.The observed cracking is initiating around the metal insert of the trial.A (b)(4) meeting was held to discuss a product escalation out of (b)(6) concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned device.Based on the performed investigation and (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Examination of the returned device confirms the reported event of trial damage/missing component.The observed cracking is initiating around the metal insert of the trial.A pra (b)(4) (preliminary risk assessment) meeting was held to discuss a product escalation out of (b)(6) concerning the attune shims.The team has determined that there is no additional patient risk associated with this issue.Although cracks are occurring, this failure mode does not lead to a patient harm of infection.The rate of infection for attune is within the state rate in the risk management report and is statistically similar to the rate of infection for the total knee class.Although a definitive root cause is not known, a combination user technique, improper technique or misuse, and the use of contraindicated chemicals (non-compliant to cleaning guidelines), may lead to weakening of the material, as seen in the returned device.Based on the performed investigation and pra (b)(4) determination of no additional patient risk, corrective action is not indicated.Continue to monitor via (b)(4).Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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