TORNIER S.A.S. TORNIER FLEX SHOULDER SYS REV INSERT 36MM 6TH B 12.5DG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number DWF361B |
Device Problems
Unstable (1667); Naturally Worn (2988)
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Patient Problem
Joint Laxity (4526)
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Event Date 11/05/2020 |
Event Type
Injury
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Event Description
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The manufacturer received a report from the national joint registry that contains unpublished collected data on the usage and the outcomes with the tornier shoulder system.The report details analysis provided for procedures performed between april 2012 ¿ may 2022.During the review of the report, it was identified that on (b)(6) 2020 a patient required revision surgery due to instability|impingement|glenoid implant wear|native glenoid surface erosion, which was not previously reported to the manufacturer.
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Manufacturer Narrative
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The reported event that could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history was not necessary because the implant affected by this complaint has been manufactured prior to 2018.As a result, this implant is expired and can no longer be put on the market or implanted.The complaint history review found no other complaint recorded for this lot number.Moreover, the post market surveillance reviews have not identified any signals for similar issues that would have challenged the efficacy and safety of this product.A review of the labeling did not indicate any abnormalities.The nature of the complaint doesn't necessitate a drawing review.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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