Catalog Number 04.01.0002 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 02/07/2024 |
Event Type
Injury
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Event Description
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The patient's humerus fractured during the humeral diaphysis (size 7) insertion.The cement was only in the distal part.A diaphysis (size 6) was used to complete the surgery.
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Manufacturer Narrative
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Batch review performed on 09-feb-2024.Lot 2242381: (b)(4) items manufactured and released on 06-dec-2022.Expiration date: 2027-11-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.
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Manufacturer Narrative
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On 18 march we have received the device involved in the event.Visual inspection performed by r&d project manager: the diaphysis does not show any signs of damage.No cement residuals are present in the distal part of the diaphysis, while minor remnants are visible on the calcar region.Given the information at hand it is not possible to determine the event root cause.
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Search Alerts/Recalls
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