SMITH & NEPHEW ORTHOPAEDICS LTD DYSPL CUP HAP 54MM W/ IMPTR; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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Catalog Number OR74120254 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Test Result (2695)
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Event Date 02/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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Event Description
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Patient suing medical personnel at the orthopaedics and traumatology clinic, independent public teaching hospital fo failure to failure to exercise due care and diligence in performing diagnostic tests and improper decisions.Revision surgery planned.
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Manufacturer Narrative
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Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Attachment: [122376 summary.Pdf].
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Event Description
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It was reported that revision surgery is planned for early 2019.High levels of metal ions have been confirmed in the medical fields at home and abroad.Despite the lack of clinical features of loosening the hip implant, an indication was given to remove the right hip prosthesis.The patient consulted a us surgeon, who advised that the implant needs to be replaced.However the patient's local polish hospital does not want take responsibility of the surgery.
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Event Description
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T was reported that a revision surgery was performed on (b)(6) 2019 due to elevated metal ions.Primary surgery was performed on (b)(6) 2006 and since 2014, the patient was diagnosed with a systemic reaction of cobalt ions emission with symptoms of neurological ¿ endocrinological complications.Despite the lack of clinical features of loosening the hip implant, an indication was given to remove the right hip prosthesis.The patient consulted a us surgeon, who advised that the implant needs to be replaced.However, the patient's local polish hospital does not want take responsibility of the surgery.
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Search Alerts/Recalls
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