ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, PROXIMAL HUMERUS, RIGHT, 11X160MM; ROD, FIXATION, INTRAMEDULLARY
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Model Number 47-2496-160-11 |
Device Problem
Migration (4003)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/16/2022 |
Event Type
Injury
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Event Description
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It was reported that the surgeon found that the proximal screw was backed out from the proper position 1 month after the initial surgery.The surgeon will continue to monitor the patient's condition.Revision surgery is not currently planned.No further patient outcome was provided.Attempts have been made and no further information has been provided yet.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: cortical bone screw, 4x26mm; catalog#: 47248612640; lot#: 3091271.Cortical bone screw, 4x28mm; catalog#: 47248612840; lot#: 3082043.Proximal humerus nail cap, 0mm; catalog#: 47248801000; lot#: 3082050.Torque limiting handle; catalog#: 27923; lot#: unknown.Report source: foreign: japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00370, 0009613350-2022-00371, 0009613350-2022-00372, 0009613350-2022-00373.
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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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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10.As no product was returned, visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.No surgical report or x-rays are available for investigation.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behavior or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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