Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667)
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Patient Problem
Unequal Limb Length (4534)
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Event Date 09/27/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a hip procedure.Subsequently, the patient was revised approximately 4 months later due to instability and leg length too long.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -02399.D10: cat# 010000999 lot# 7453204 g7 screw 6.5mm x 30mm.Cat# 010001000 lot# 7447004 g7 screw 6.5mm x 35mm.Cat# 010000997 lot# 7446994 g7 screw 6.5mm x 20mm.Cat# 010000999 lot# 7413988 g7 screw 6.5mm x 30mm.Cat# 31-323230 lot# 65975111 3.2mmx30mm rnglc+ acet drl bit.Cat# 110010265 lot# 65453019 g7 osseoti multihole 54mm f.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon reassessment of the reported event, it was determined to be not reportable as this device would not cause the reported event.The initial report should be voided.
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Event Description
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No further information at the time of this report.
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Search Alerts/Recalls
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