Catalog Number 01.04223.030 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problem
No Code Available (3191)
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Event Date 08/05/2015 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturer did not receive devices for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer's reference number of this file is (b)(4).
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Event Description
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It was reported that the patient was implanted a inverse/reverse screw system, 4.5-30 on (b)(6) 2014.The patient described a clunking noise and indicated it hindered movement.The surgeon and the patient decided to revise the shoulder.During the revision on (b)(6) 2015 it was determined that the poly had dislodged.The screws were not removed during the revision.
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Manufacturer Narrative
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During the trend analysis no trend was identified.The compatibility check was performed from surgical technique lit.No.06.01276.012 and showed that the product combination was approved by zimmer biomet.Review of incoming information : the patient described a "clunking" noise and indicated it hindered movement.Dr.(b)(6) and the patient decided to revise the shoulder.During the revision it was determined that the poly had dislodged.The surgeon was concerned that the locking mechanism failed and requested the poly analyzed.Four x-rays with poor quality were provided.The screws could be seen only on two of the four x-rays.It seems that the implant was correctly implanted.In the available surgical reports no inconspicuousness regarding screw implantation could be found.The device analysis could not be performed as the device was not returned for investigation.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The involved anatomical shoulder inverse/reverse screws were not affected at all.The dislodgment of the pe inlay is related to (b)(4) only.This is a split case with (b)(4).Zimmer (b)(4) considers this case as closed.(b)(4).
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Search Alerts/Recalls
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