Catalog Number UNK HIP FEMORAL HEAD METAL SRO |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the dr.Received the email over a month ago and the rep booked the kit in.Dr made a mistake in that the rep booked 12/14 heads as opposed to 11/13 heads which would be compatible with srom hip.Dr.Doesn¿t know how he didn¿t notice the request for srom heads, but somehow he didn't.So yesterday morning, he arrived early to check all the instruments and implants, was happy¿ it wasn¿t until he saw the xrays as the surgical team were prepping the patient¿s skin that he noticed the srom stem.He immediately informed respected person that he did not have the necessary heads.He tried to get some 11/13 heads from the office in leeds, unfortunately there wasn¿t any available on the day.The surgeon decided to wake the patient up and reschedule for another day as he wanted to just change the head and use a constrained liner.
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Manufacturer Narrative
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Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.No evidence was found indicating product error was a contributing factor.The need for corrective action was not identified.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot:a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Search Alerts/Recalls
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