SMITH & NEPHEW, INC. UNKN SYNERGY HIP STEM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number UNKN01101000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 03/17/2021 |
Event Type
Injury
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Event Description
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It was reported that on literature review ¿short-term effect of total hip arthroplasty via direct anterior approach with general prosthesis.Author: peng zhaohua, zhao zujie, yang bin, yang jun¿ 4 patients presented injury of lateral cutaneous nerve while using unkn reflection metal cup impl, 1 patient presented blunt cutting injury of hip tensor fasciae latae while using unkn reflection metal cup impl, 1 patient presented intraoperative fracture of greater trochanter while using unkn synergy hip imp 1 patient presented intraoperative cleavage fracture of calcar femorale while using unkn synergy hip imp, 1 patient presented posterior dislocation of the hip while using unkn fem head impl memphis and 1 patient presented posterior dislocation of the hip while using unkn reflection liner.
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Manufacturer Narrative
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The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, there was an intraoperative fracture of greater trochanter.Without the requested clinical information/documentation, further assessment of the reported events could not be provided and the root cause beyond those reported in the article could not be concluded.The patient impact beyond the reported events could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.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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