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Catalog Number 320-15-38 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 12/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Revision due to infection.
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Manufacturer Narrative
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After further review of additional information received the following sections date of report, event, relevant tests/laboratory data, other relevant history, date rec¿d by mfr, pma/510k, if follow-up, what type and adverse event problem have been updated accordingly.Serial # range: (b)(4), mfg: 3/22/2016 and exp: 3/20/2021.Serial # range: (b)(4), mfg:4/5/2016 and exp 3/31/2021.Serial # range: (b)(4), mfg:4/8/2016 and exp 4/6/2021.Serial # range: (b)(4), mfg:4/12/2016 and exp:4/10/2021.In a review of the labeling, it is a known complication that there may be superficial or deep infections for shoulder replacement devices.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of patient infection of the shoulder joint devices is most likely due to the patient's underlying conditions.This device is used for treatment, not diagnosis no information has been provided.Asked, not answered: sex, weight, ethnicity and race.No device evaluation pending.
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Event Description
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It was reported from the united kingdom that a patient experienced a revision surgery shoulder device due to infection.The patient presented the week before the revision surgery with pus seeping from the operative scar.The implants were removed, and antibiotic balls and an antibiotic cement spacer was inserted.Some of the explanted devices were sent to microbiology for analysis, all devices were disposed of.The revision surgery had no delays.The representative was only able to retrieve the serial numbers, that were appropriately reported.There is no indication or complaint that the devices malfunctioned.No additional information has been provided.This is one of thirteen products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00868, 1038671-2017-00869, 1038671-2017-00870, 1038671-2017-00871, 1038671-2017-00872, 1038671-2017-00874, 1038671-2017-00875, 1038671-2017-00876, 1038671-2017-00877, 1038671-2017-00878, 1038671-2017-00879 and 1038671-2017-00880.
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Search Alerts/Recalls
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