Model Number N/A |
Device Problems
Mechanical Problem (1384); Noise, Audible (3273)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product remains implanted in the patient.Concomitant medical products: unknown ceramic liner, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00509.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
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Event Description
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It was reported during a clinical study an unknown biolox ceramic head and the unknown liner were making a squeaking noise.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00509-1.As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint database could not be performed as item numbers and lot numbers are unknown.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
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Event Description
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It was reported during a clinical study an unknown biolox ceramic head and the unknown liner were making a squeaking noise.No impact or consequences to the patient, or the user were reported.
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Search Alerts/Recalls
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