SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTLESS (TI/HA); PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/31/2020 |
Event Type
Injury
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Event Description
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It was reported that on literature review "excellent midterm survival and functional outcomes of a fully hydroxyapatite-coated cementless stem: first results of a prospective multicenter study", 1 patient underwent a revision surgery where the stem was revised 6 weeks after initial surgery due to unknown reasons.No further information is available.There is no information within the study to determine whether these adverse events occurred in (b)(6) or in (b)(6).
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Willburger, r.E., heukamp, m., lindenlaub, p., efe, t., peterlein, c.D., & schüttler, k.F.(2020).Excellent midterm survival and functional outcomes of a fully hydroxyapatite-coated cementless stem: first results of a prospective multicenter study.Arthroplasty today, 6(2), 201-205.Doi: 10.1016/j.Artd.2020.01.009.
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Manufacturer Narrative
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H3, h6: in the literature article of willburger et al.2020 [1], it was reported that, 1 patients had to undergo a revision surgery due to unknown reasons six weeks after a primary total hip replacement surgery with the polar system.The devices, used in treatment, were not returned for investigation and the part and batch number of the reported complaint are not known.Therefore, it is not possible to investigate whether the reported devices met manufacturing specification upon release for distribution.The severity and the failure mode are covered through our risk management.A thorough medical investigation could not be performed due to insufficient information.Several failures, which could lead to a revision surgery are listed among potential adverse device effect in the hip instruction for use of smith and nephew (lit.No.12.23 ed.03/21).Based on the performed investigations, the failure mode and the relationship between the devices and the reported events cannot be confirmed.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event and it is not possible to perform a review of past corrective actions.No probable cause can be determined and no further actions will be taken to this date.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor the devices for further similar issues.
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Manufacturer Narrative
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Internal complaint reference number: case-(b)(4) section h6 (type of investigation) was corrected.
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