TORNIER INC UNKNOWN 29 FULL WEDGE BASEPLATE- PERFORM REVERSE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Catalog Number UNK_WTB |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Bacterial Infection (1735); Foreign Body In Patient (2687); Implant Pain (4561)
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Event Date 10/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.
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Event Description
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It was reported that a patient was experiencing ongoing pain for over a year.Aspiration confirmed the presence of c.Acnes bacteria as the cause of infection.The patient was revised.All humeral components were taken out, screw driver broke off in the patient, and baseplate couldn't be removed.The broken fragment of the screwdriver was left in the patient.This was during a staged procedure.Procedure had to be adapted to account for the fact that all the implants could not be explanted from the patient.Antibiotic spacer was put in.Patient had had previous cuff repair on their shoulder.
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Search Alerts/Recalls
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