Catalog Number 110044500 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Joint Disorder (2373); Not Applicable (3189)
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Event Date 08/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The patient was revised to address pain and loss of function.Doi: (b)(6) 2015; dor: (b)(6) 2018; unknown affected side.
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Event Description
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The duration of the surgery was 90 minutes.The affected side is unknown.The patient was experiencing loss of function which includes range of motion, rotator cuff tear and instability.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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