SMITH & NEPHEW, INC. R3 SHELL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 02/09/2016 |
Event Type
Injury
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Event Description
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It was reported that the patient had persistent back and leg pain that failed to improve with non-operative management.He underwent uneventful surgery and routine post op care.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical evaluation was conducted and the clinical information provided, of the ¿osteolytic/metallosis and synovial reaction¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause of the dislocations cannot be concluded based on the information provided.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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Manufacturer Narrative
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The associated complaint devices were not returned.A clinical evaluation was conducted and the clinical information provided, of the ¿osteolytic/metallosis and synovial reaction¿ may be consistent with a reaction to metal debris.However, the source and the root cause cannot be determined with the available documentation.The root cause of the dislocations cannot be concluded based on the information provided.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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