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Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Pain (1994)
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Event Date 03/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Associated products: tibial bearing ref 189022, lot 082450; cr femoral ref.183022, lot j3813089; cement ref.4720502083-1, lot a727b05290.This product is manufactured by biomet (b)(4) orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.Device not returned yet.
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Event Description
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It has been reported that on (b)(6) 2019 the patient underwent a primary knee prosthesis with vanguard.The patient started with constant pain which became disabling.The surgeon decided to review the total prosthesis.During the revision surgery on (b)(6) 2021, a total detachment of the vanguard tibial plate was detected, without any cement residue at the base.
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Event Description
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It has been reported that on (b)(6) 2019 the patient underwent a primary knee prosthesis with vanguard.The patient started with constant pain which became disabling.The surgeon decided to review the total prosthesis.During the revision surgery on (b)(6) 2021, a total detachment of the vanguard tibial plate was detected, without any cement residue at the base.
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Manufacturer Narrative
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(b)(4).D10.Associated products: tibial bearing ref (b)(4), lot 082450; cr femoral ref (b)(4), lot j3813089; cement ref (b)(4), lot a727b05290.G5: this product is manufactured by biomet spain orthopaedics, s.L.And is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet warsaw manufactures a similar device that is cleared or distributed in the united states under 510(k) number k945028.
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Search Alerts/Recalls
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