Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/18/2021 |
Event Type
Injury
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Manufacturer Narrative
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Medical products: blunt tip screw, 4x48mm; catalog#: 47-2486-048-40; lot#: 3024731.Proximal humerus, right, 11x160mm; catalog#: 47-2496-160-11; lot#: 3051302.Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3039376.Cortical bone screw, 4x32mm; catalog#: 47-2486-132-40; lot#: 3010610.Proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3025182.Proximal humerus nail cap,11x2.5mm; catalog#: 47-2488-011-02; lot#: 3038374.Therapy date: (b)(6) 2021.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on an unknown side with an ann nail system.A week post the implantation surgery the surgeon noticed that the third blunt screw had backed out from its proper position.Hence, the patient underwent a revision surgery during which the third blunt screw was explanted.
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Manufacturer Narrative
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Additional information which was received on sep 03, 2021.D10- medical product: torque limiting handle; item# : 27923; lot# : unknown.Lg cann screwdriver handle; item# : 214149000; lot# : unknown.Therapy date: (b)(6) 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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Patient was implanted on an unknown side with an ann nail system.A week post the implantation surgery the surgeon noticed that the third blunt screw had backed out from its proper position.Hence, the patient underwent a revision surgery during which the third blunt screw was explanted.
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Manufacturer Narrative
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It has been realized during further investigations that this device is not the main product.The incident is reported with 0009613350-2021-00458 and 0009613350-2021-00446.Therefore, this mdr is obsolete.Please invalidate the case from your system.Zimmer¿s reference number of this file is (b)(4).
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Event Description
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See h10.
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Search Alerts/Recalls
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