ZIMMER BIOMET, INC. NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ STANDARD PRIMARY PATELLA; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/11/2020 |
Event Type
Injury
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Event Description
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It was reported that a patient was revised approximately two years and two weeks post implantation due to unknown reasons.There is no additional information available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2022-02333, 0001822565-2022-02334, 0001822565-2022-02335 concomitant medical products: femur trabecular metal (ps) narrow porous, item# 42500205801, lot# 62927480.Natural tibia trabecular metal two-peg porous fixed bearing left size c, item# 42530006401 ,lot# 77007007.Articular surface fixed bearing (ps) left 14 mm height, item# 42512400414, lot# 63506485.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.
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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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This follow-up is being submitted to relay additional information.Updated: b4, b5, g3, g6, h1, h2, h3, h6, and h10.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised a second time for an unknown reason.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot 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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