ZIMMER BIOMET, INC. FEMUR TRABECULAR METAL CRUCIATE RETAINING (CR) STANDARD POROUS; PROSTHESIS, KNEE
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Model Number N/A |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Information (3190)
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Event Date 03/23/2020 |
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, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 42532007102, tibial component, lot # 63917427.42522100812, articular surface, lot # 63960961.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 3007963827 - 2020 - 00111.3007963827 - 2020 - 00112.
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Event Description
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It was reported that approximately 2 years post implantation, the patient underwent a revision procedure due to unknown reasons.Attempts for additional information have been made and none has been provided.
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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 update/corrected updated: b4, b5, g4, g7, h2, h6 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 further reported that the patient was revised due to instability.No further information was provided.
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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, g4, g7, h1, h2, h3, h6, h10 no devices were received; therefore the condition of the components is unknown.Review of the device history records identified no related deviations or anomalies during manufacturing.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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