Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: cat# 010002632 lot# unk g7 prov neutral liner 36mm f; 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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Event Description
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It was reported that the tip of the shell inserter and trial liner broke.The patient was undergoing a right hip surgery.There was no reported patient impact, no medical or surgical intervention, no surgical delay, no surgical complications, and no foreign body retained.No additional information was available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.D10: cat# 010002632 lot# zb150102 g7 prov neutral liner 36mm f.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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No further event information is 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 updated: b4 g3 g6 h2 h6 h10 visual examination of the returned product identified the inserter had a fracture at the top of the threads along with damage to the threaded tip.There was also damage to the internal threads and the strike plate of the device.Complaint confirmed based on the evaluation of the returned product.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined 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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There is no additional information available at the time of this report.
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Search Alerts/Recalls
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