SMITH & NEPHEW, INC. UNKN R3 SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Joint Dislocation (2374)
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Event Date 07/26/2013 |
Event Type
Injury
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Event Description
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It was reported that on literature review "early failure of the polarstem total hip arthroplasty¿can the australian njr tell us the full story?", one (1) patient who initially underwent primary thr implantation with a combination of a cementless collared polarstem and an r3 acetabular cup, required an additional surgery six (6) days postoperatively where a girdle stone excision arthroplasty was performed due to postoperative dislocation.The outcome of this patient is unknown.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Lee, p.Y., & evans, a.R.(2014).Early failure of the polarstem total hip arthroplasty¿can the australian njr tell us the full story?.The journal of arthroplasty, 29(3), 609-611.Doi: http://dx.Doi.Org/10.1016/j.Arth.2013.07.040.
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Manufacturer Narrative
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H6, health effect - impact code filed updated.H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot 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 patient anatomy, fit/sizing issue, 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.
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