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Catalog Number 4710500394-3 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This is a combination product (b)(4).Report source, foreign - event occurred in (b)(6).The device manufacturing quality record indicate that the released product met all requirements to perform as intended.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.
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Event Description
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It was reported that during hip artroplasty, a cement cup was implanted.A first attempt was made, but the cement did not bond with the acetabulum.The acetabular cup together with the cement tipped out of the acetabulum.A second attempt was made with another cement batch, the cement did not bond with the acetabulum, and the implant again tilted out of the acetabulum.Eventually, a cementless cup was implanted.The events result in a 45 minutes delay in procedure.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This is a combination product (b)(4).This follow-up report is being submitted to relay additional information.The following section has been updated: b4, g3, g6, h2, h3, h6, h10.The device manufacturing quality record indicate that the released product met all requirements to perform as intended.Complaint history identified no additional complaints for the reported part/lot combination.A definitive root cause cannot be determined.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions.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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Event Description
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It was reported that during hip artroplasty, a cement cup was implanted.A first attempt was made, but the cement did not bond with the acetabulum.The acetabular cup together with the cement tipped out of the acetabulum.A second attempt was made with another cement batch, the cement did not bond with the acetabulum, and the implant again tilted out of the acetabulum.Eventually, a cementless cup was implanted.The events result in a 45 minutes delay in procedure.No adverse events have been reported as a result of the malfunction.
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Search Alerts/Recalls
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