Catalog Number DKY067 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686); Swelling/ Edema (4577)
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Event Date 11/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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It was reported that patient (b)(6) had a "surgical debridement rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened on (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).
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Manufacturer Narrative
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The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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It was reported that patient (b)(6) had a "surgical debridement rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened on (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).
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Event Description
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It was reported that patient (b)(6) had a "surgical debridment rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened in (b)(6) 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).
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Manufacturer Narrative
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Corrections: refer to g1 reporting entity and reporting contact.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between (b)(4), exceptionally up to (b)(4) and beyond, mainly depending on the respective surgical procedure and the typical patient population.¿ a review of the labeling did not indicate any abnormalities.In case the item and / or substantive information will become available in future that suggests otherwise; the file will be reviewed.
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Manufacturer Narrative
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Please note the following correction: g1 (manufacturing site).
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Event Description
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It was reported that patient 001-001 had a "surgical débridement rt elbow and excision of sinus tract and synovial biopsies.Intravenous antibiotics post operatively." (re-operation without implant extraction), following a local complication that happened in april 2021 ("breakdown of skin over point of elbow with swelling and discharging straw coloured fluid." infection in the operated area resolved without sequelae).
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Search Alerts/Recalls
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