SMITH & NEPHEW, INC. UNKN R3 IMPL; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number UNKNOWN |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 10/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).Teoh, k.H., whitham, r.D., golding, d.M., wong, j.F., lee, p.Y., & evans, a.R.(2018).R3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up.The journal of arthroplasty, 33(2), 460-463.Doi: https://doi.Org/10.1016/j.Arth.2017.09.059.
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Event Description
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It was reported that, on the literature review "r3 cup does not have a high failure rate in conventional bearings: a minimum of 5-year follow-up", one (1) patient who underwent revision surgery of the uncemented polarstem due to a periprosthetic femoral fracture experienced a fall and the hip dislocated two (2) times after this revision.As the dislocation was irreducible, she required an open reduction with revision of the r3 acetabular cup to a two (2) mm upsized cup from the same family to accommodate a larger femoral head for increased stability.The patient's outcome is unknown.No further information is available.
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Manufacturer Narrative
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H10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per the complaint details, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.The contribution of the device 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 product involved, our investigation could not proceed.Should the device 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.Internal complaint reference number: (b)(4).
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