Catalog Number UNK KNEE STEM ATTUNE REVISION |
Device Problem
Difficult to Advance (2920)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/12/2021 |
Event Type
malfunction
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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 patient had revision of rt tka (b)(6) 2018.Revision of the femoral components (b)(6) 2021.The femur was reamed to the 8th mark and prepped for a 12 stem.Broached up to a 40 femoral sleeve with 8mm distal augments.During trialing it was evaluated that the femoral trial construct did sit down.The decision was made to proceed with the construct trialed and was assembled appropriately on the back table by the surgeon.It is noted that the 40 sleeve is not recommended to be used with a 3 crs femur but was engaged with no rotation in sleeve femoral construct.The 12 x 110 stem was attached and implanted.During cementing and implantation, the femoral construct would not go down and the surgeon extracted the implant and put in the construct with a 10x110 stem.This construct also set proud and would not go completely down.It is noted that the anterior bone is absent and not restricting the component from advancing.The surgeon then extracted the femoral components prior to cement hardening.The femur was re prepped and a trial assembled and trialed for a 35 sleeve with 4mm distal augments and 12 stem.This construct is what was put in.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.
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Event Description
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Questions: a.Was there any adverse consequences that affected the patient because of the reported event? b.The reported product "154900103" is invalid in ecm and as400.Please provide valid product and/or lot number of the product.C.Please clarify if the trials played a part in the seating errors.D.Please provide product and lot number of the 12x110 stem.Answers for your questions: a.Not that the rep has been informed of c.In the copied replied statement it is clearly noted that the trial construct was confirmed to sit down.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 and d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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