STRYKER GMBH PRESS-FIT HUMERAL STEM 14MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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Model Number 5567-P-3014 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)
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Event Date 10/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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As reported: "patient experienced excess drainage from incision site on (b)(6) 2020 that persisted over 2 days.Patient started taking cephalexin 250 mg 4x/day on (b)(6) 2020.Patient reported improvement on (b)(6) 2020.Patient will continue to take medication for two weeks and will follow-up for wound check.(b)(6) 2020: incision began bleeding again on (b)(6) 2020.Patient seen on (b)(6) 2020, labs ordered on (b)(6) 2020.Due to excess drainage, plan will be revision surgery.".
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Manufacturer Narrative
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The reported event 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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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.However, drainage from the incision site could be more attributable to the user related (improper wound closure) or predominantly patient factor (premedical condition, failure to follow postoperative behavioral requirements or improper wound healing etc.).If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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As reported: "patient experienced excess drainage from incision site on (b)(6) 2020 that persisted over 2 days.Patient started taking cephalexin 250 mg 4x/day on (b)(6) 2020.Patient reported improvement on (b)(6) 2020.Patient will continue to take medication for two weeks and will follow-up for wound check.11/2/2020: incision began bleeding again on (b)(6) 2020.Patient seen on (b)(6) 2020, labs ordered on (b)(6) 2020.Due to excess drainage, plan will be revision surgery.".
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Search Alerts/Recalls
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