Model Number N/A |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Local Reaction (2035)
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Event Date 04/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unk, unknown versys head, unk; unk, unknown liner, unk; unk, unknown cup, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06245.
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Event Description
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It was reported patient received a right revision procedure seven years post-implantation due to elevated metal ion levels.Mri results demonstrated adverse local tissue reaction around the prosthesis and pseudotumors around the hip.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number/ lot number of device involved in the incident is unknown and due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports:0001822565-2018-01124-1.Reported event was unable to be confirmed as limited information received from the customer.Review of the device history records did not identify any deviations or anomalies related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Manufacturer Narrative
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Upon reassessment of the reported event, the stem was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, the stem was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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