Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).D10: cat# unk lot# unk unknown size 7 broach.Customer has indicated that the product remains implanted and will not be returned to zimmer biomet for investigation.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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It was reported that the stem implant was oversized by at least one complete size compared to the broach.The surgeon broached multiple times, with the broach going on very easily but the stem sat about 5 or 6mm proud.The surgeon had to drop from a standard to a -6 neck length, and the stem was implanted.It was determined to likely be an implant issue since there hasn't been an issue with the broach in previous cases.Surgical technique was utilized.There were no patient conditions or anatomy that contributed to the event.There was no patient impact and no surgical delay.No additional information available.
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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 and corrected.The following section was corrected: d4.Product will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.
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Search Alerts/Recalls
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