SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
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Catalog Number 71335554 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Joint Dislocation (2374)
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Event Date 01/01/1901 |
Event Type
Injury
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Event Description
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It was reported that recurrent dislocations on (b)(6) 2017 & (b)(6) 2018 occurred.
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Manufacturer Narrative
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The associated complaint devices were not returned.The clinical/medical team concluded, the doctor¿s statement that the patient¿s need for a 3rd revision, to ¿increase the head size and/or mobility¿and without a revision attempt, that certainly she will dislocate at some point again¿ indicates that the likely root cause for her multiple post-revision dislocations is due to an inappropriate head size, or another reason for unexpected joint laxity.To date, there is no indication that the patient has had the 3rd revision performed.No further clinical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.
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Search Alerts/Recalls
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