SMITH & NEPHEW, INC. JOURNEY II UK OX FEM SZ 5 LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74026025 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 03/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
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Event Description
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It was reported that, after a left medial unicompartmental knee replacement had been performed on (b)(6) 2019 to address a medial gonarthrosis symptoms, the patient required a revision surgery on (b)(6) 20219 for an unknown reason.The patient presented swelling and wound healing disorder.The journey ii unicompartmental system was converted to a tka on (b)(6) 2019 due to unspecified complications and/or adverse events.The outcome of this patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered retrospectively; therefore, additional information is not known.
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Manufacturer Narrative
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B5: describe event or problem, d4: catalog number and unique identifier (udi) # ,d11: concomitant medical products and therapy dates and g5: 510(k) #.
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Event Description
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It was reported that, after a left medial unicompartmental knee replacement had been performed on (b)(6) 2019 to address a medial gonarthrosis symptoms, the patient required a revision surgery on (b)(6) 2019 for an unknown reason.The patient presented swelling and wound healing disorder.The journey unicompartmental system was converted to a tka on (b)(6) 2019 due to unspecified complications and/or adverse events.The outcome of this patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered retrospectively; therefore, additional information is not known.
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Search Alerts/Recalls
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