WALDEMAR LINK GMBH & CO.KG ENDO-MODEL- M, ROTATIONAL KNEE PROSTHESIS; KNEE-JOINT PROSTHESIS RIGHT, SMALL, COCRMO/TINBN, WITH PATELLAR FLANGE
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Model Number 15-3816/11#02 |
Device Problems
Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924)
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Event Date 01/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
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Event Description
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Tinbn-coated hinged knee was implanted (b)(6) 2022 as a temporary spacer for the 1st stage in a planned 2 stage revision for infection.This tinbn-coated hinged knee was used as a spacer because of the patient's nickel allergy.The patient underwent revision surgery (b)(6) 2022.The femoral component, tibial polyethylene bearing, and femoral augment were replaced (impacted onto the existing femoral stem in situ).Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components (b)(6) 2022 (b)(4), and subsequent revisions (b)(6) 2022 and (b)(6) 2022 for infection (previously reported in complaint (b)(4).[customer].
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Manufacturer Narrative
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The rewiev of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
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Event Description
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Tinbn-coated hinged knee was implanted (b)(6) 2022 as a temporary spacer for the 1st stage in a planned 2 stage revision for infection.This tinbn-coated hinged knee was used as a spacer because of the patient's nickel allergy.The patient underwent revision surgery (b)(6) 2022.The femoral component, tibial polyethylene bearing, and femoral augment were replaced (impacted onto the existing femoral stem in situ).Prior surgeries on this knee include: primary and revision tka (not link product), revision with link compassionate use components 2022-08-10 (comp-053), and subsequent revisions 2022-09-26 and 2022-10-07 for infection (previously reported in complaint 2022-053) and for dissociation of femoral component from stem (same stem as previous event in complaint 2023-060).[customer].
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