Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Implant date: unknown month and day in 2012.Concomitant devices: ref 183128tnbn lot unk tinbn coated vanguard femur 65mm.Ref ep-183644 lot unk vanguard tibial bearing 14mm x 71/75mm ps.Ref 184764 lot unk series a standard patella 3 pegs 31 x 8mm.Report source -foreign: (b)(6).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.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.
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Event Description
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Left tka performed on an unknown date in 2012.Subsequently, the patient was revised due to aseptic loosening of the tibial component (b)(6) 2018.
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Manufacturer Narrative
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(b)(4).D6a: implant date: unknown month and day in 2012.D10: concomitant devices: ref (b)(4) lot unk tinbn coated vanguard femur 65mm.Ref(b)(4) lot unk vanguard tibial bearing 14mm x 71/75mm ps.Ref (b)(4) lot unk series a standard patella 3 pegs 31 x 8mm.G2: report source -foreing: belgium.G5: this product is manufactured by biomet sapin 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.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.In addition the lot number is unknown and the principal investigator of the study has declined to provided additional information.H3 other text: product location is unknown.
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Event Description
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Left tka performed on an unknown date in 2012.Subsequently, the patient was revised due to aseptic loosening of the tibial component (b)(6) 2018.
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Search Alerts/Recalls
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