SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
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Catalog Number 71338952 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 08/27/2018 |
Event Type
Injury
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Event Description
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It was reported that revision surgery was performed.Surgeon revised r3 alumina on alumina.Patient was complaining of pain, thought ceramic liner might be fractured.It was found that the ceramic liner was not fractured, implants were fine.Surgeon changed liner to a poly liner and a new femoral head was put on.No issues, no delays, no injuries.
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Manufacturer Narrative
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The associated complaint device was not returned for evaluation.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing or product specifications for listed batch did not reveal abnormalities that could have contributed to the reported issue.Our clinical/medical team concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the actual product involved, 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.We consider this investigation closed.
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