Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2022 |
Event Type
Injury
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Event Description
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It was reported that the wrong size femoral head was implanted on the primary surgery.The patient was taken to the post operative area for recovery.A post op x-ray was taken and it was realized that the wrong size femoral head had been implanted.The patient was returned to the or and a revision surgery was performed to put in the correct size femoral head.During the primary surgery, a size 50 acetabular shell with a 32mm neutral liner was implanted.A 36mm +5 head was implanted.During the revision surgery, a 32mm +5 femoral head was implanted.The primary surgery and the revision surgery occurred on the same date.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: unknown hip.
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Manufacturer Narrative
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(b)(4).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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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.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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