Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that upon opening the box of the taperloc stem, it was noticed that the stem had breached the sterile plastic container.It was sticking out approximately a centimeter, making it non-sterile.No external defects to the box.There is no additional information available at the time of this report.
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Event Description
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There is no update to the prior event description provided.
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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 visual evaluation of the returned product/provided photos identified damage to the sterile packaging (blister and pouch).Sterility has been compromised.The reported event has been confirmed by evaluation of the returned product/provided photos.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The condition of the device when it left zimmer biomet is considered conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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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Search Alerts/Recalls
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