SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Model Number 71342804 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Deformity/ Disfigurement (2360); Joint Dislocation (2374)
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Event Date 11/02/2017 |
Event Type
Injury
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Event Description
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It was reported that, from data obtained from the national joint registry (uk) for twenty thousand sixty three (20063) patients who underwent primary implantation of thr - smith and nephew components comprising a cementless polarstem and a combination of several femoral heads, liners and cups between 23-jul-2007 and 19-sep-2021, a total of two hundred thirty one (231) hips were revised due to several reasons, which were accounted for a total of two hundred sixty nine (269) preoperative diagnosis.From these, nine (9) were indicated due to malalignment of the acetabular cup prosthesis.The specific details in regards of the identity of the explanted components and the ones implanted in exchange are not known.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H6, health effect - impact code was updated.H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information could be provided to assist with this clinical investigation as the data collected from the national joint registry of the united kingdom.Per case details, no further information is available.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined.Should any additional clinical information be provided this complaint will be re-evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of devices or user/procedural variance.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that, after a right thr index surgery performed on (b)(6) 2016 to address osteoarthritis symptoms, the patient experienced a dislocation/subluxation that made necessary a revision surgery on (b)(6) 2017.During this procedure, the femoral head and the acetabular liner were explanted and replaced with similar devices.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem and an r3 shell and that required a revision surgery due to specific reasons.As such, no further information will be available.
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Manufacturer Narrative
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Results of investigation: this complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry from united kingdom that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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