Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Metal Related Pathology (4530)
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Event Date 08/07/2023 |
Event Type
Injury
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Event Description
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It was reported that patient underwent an initial total hip arthroplasty and approximately 6 years later a revision surgery was performed due to elevated metal on blood serum levels and metallosis.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4).D10 ¿ medical devices: unknown cls stem; item# unknown; lot# unknown.Unknown metasul head; item# unknown; lot# unknown.Unknown continuum 52 mm uni-hole cup; item# unknown; lot# unknown.G2 ¿ foreign: australia.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2023 - 00504 and 0009613350 - 2023 - 00505.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.H3 other text : product is unknown.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records could not be performed due to missing lot number.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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