Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 05/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 431185 816110 s1s hip head cement mold 64mm, 431187 s1s hip neck adapter +6mm, palacos r+g 2x40g lot number 82984502.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05500, 0001825034 - 2019 - 05502.
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Event Description
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It was reported that after a complicated course post left total hip arthroplasty, the patient underwent implantation of an antibiotic spacer.During the hospital stay, the patient experienced outward rotation and lengthening of the left leg.The patient underwent closed reduction under anesthesia due to subluxation of the cement spacer.The hip was reduced and the patient discharged without further complication.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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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 report is being submitted to relay additional information.The following sections were updated/corrected.Corrected: d4.Updated: d4; h4.
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Search Alerts/Recalls
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