Model Number L20312 |
Device Problems
Fracture (1260); Loss of Osseointegration (2408); Unintended Movement (3026)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Inadequate Osseointegration (2646); Not Applicable (3189); No Code Available (3191)
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Event Date 05/30/2020 |
Event Type
Injury
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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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Event Description
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It was reported that the surgeon believes that the stem fractured inter-op.The patient experienced pain from the beginning and it progressively got worse, up on review of the follow up x-rays the greater had fractured and propagated down the shaft.The stem had also subsided down.Surgeon did a reclaim but we had an issue with the 40 mm neck trial where the bolt that locks the version was stuck in the locked position.This prevented him form doing a final trial before he placed the real proximal body which was an 85 x 40.He decided to move forward with that size but when he relocated the hip it was too tight and long.We ended up removing the 85 body and switching it to a 75.The 85 body was wasted do to the failure of the trial neck.Doi: unknown, dor: (b)(6) 2020, affected site: unknown.
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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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.H10 additional narrative: added: h6 (patient code).H6 patient code: no code available (3191) used to capture the surgery prolonged.
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Search Alerts/Recalls
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