Model Number 5450-50-501 |
Device Problem
Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Cyst(s) (1800); Edema (1820); Fall (1848); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
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Event Date 12/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Depuy smartset ghv litigation letter received.Depuy smartset ghv litigation letter alleged that plaintiff experienced severe pain which x-rays revealed gross loosening of the tibial component of a competitor left knee prosthetic.Doi: (b)(6) 2016, dor: (b)(6) 2017 left knee.
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Manufacturer Narrative
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(b)(4).The device associated with this report was not received for examination.Review of the device history records did not reveal any non-conformances.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6 (no code available (3191) is used to capture the medical device removal).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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(b)(6) 2016: patient undergoes bilateral tkas with competitor implants and smartset cement x 4 (2 cements for each le) (b)(6) 2017: patient c/o lle swelling and tightness.Dvt is ruled out and patient is eventually diagnosed with lymphodema.Patient states he scratched his leg on a dirty pipe.(b)(6) 2017: patient undergoes a left knee revision for a fractured tibial tray with loosening at unknown interface.Surgeon states there is a contained cavity defect on the medial side of the tibia.Competitor implants and cement are implanted.(b)(6) 2019: patient undergoes a right knee revision for loosening of the tibial tray at unknown interface.Tray is noted to have tilted into varus and a cyst is located within the proximal tibia requiring screw fixation.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate added: b7.
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Event Description
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Medical records were reviewed on 05 mar 2020.Multiple nurses¿ notes, physician¿s clinic notes, and pathology reports were provided.The following new events were captured: (b)(6) 2017: intraoperative synovial tissue pathology report identifies foreign body giant cell reaction and inflammation.
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report. h10 additional narrative: added: b5, b7, d11 and h6.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Medical records were reviewed to identify patient harms/product issues.Left knee: in additional to the previous harms reported prior to revision, the patient was also experiencing effusion, cyst, and experienced a fall.
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Manufacturer Narrative
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Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Medical records captured neurological issues surrounding the patient's cervical fusion surgery performed on (b)(6) 2018.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : update 12-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : device history reviewed 22 aug 19 0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Expiry date: 31-aug-17.Dmf# - 13704 , trade name ¿ gentamicin sulphate , active ingredient(s) ¿ gentamicin sulphate , dosage form - powder , strength ¿ 1.0g active in our cements.
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Search Alerts/Recalls
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