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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Host-Tissue Reaction (1297); No Information (3190)
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Event Date 10/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: catalog number:us157854, lot number: 160270, brand name: m2a magnum cup; catalog number: 192015, lot number: 407340, brand name: femoral stem; catalog number: 139254, lot number: 452400, brand name: m2a magnum taper.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02455.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
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Event Description
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It was reported that the patient was revised due to unknown reasons approximately 9 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, d4, g4, g7, h2, h3, h4, h6, h10.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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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Event Description
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It was reported that the patient was revised due to unknown reasons approximately 8 years post implantation.No further event information available at the time of this report.
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Event Description
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It was reported that the patient was revised approximately 8 years post implantation due to pseudotumor.No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: pathology report reviewed.Findings include pseudotumor left hip from soft tissue collection and acetabular shell and femoral head submitted for gross analysis only.Device was returned and evaluated.Upon visual inspection the head of the device has had the finish worn off of the outside radius.The additional information does not change the outcome of the previous investigation.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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Search Alerts/Recalls
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