Catalog Number 102407300 |
Device Problems
Loss of or Failure to Bond (1068); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Joint Disorder (2373); Numbness (2415); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 01/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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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Sigma litigation record received.Litigation record alleges pain and instability.Doi: (b)(6) 2012; dor: (b)(6) 2019; left knee.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > the device associated with this report was not received for examination.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 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.Corrected: a2 (dob) 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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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: a2, d2b, d4 (lot, catalog, expiration date, udi), d11, g5, h4, h6 (no code available (3191) is used to capture the device revision or replacement).Corrected: a1, d1, d2.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 added: h6 (patient,device).Corrected: h6 (device).No code available is used to capture joint instability and device revision or replacement.
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Event Description
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Patient suffered from major bleed.
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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.H10 additional narrative: added: h6 (patient).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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Post primary bilateral knee arthroplasty, the patient was experiencing walking difficulty.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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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 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.E3 initial reporter occupation: lawyer.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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On (b)(6) 2012, the patient underwent primary bilateral knee replacements with implantation of depuy unicompartmental products bilaterally.There were no indicated intra-operative complications.In addition to the previously indicated issues, the patient was also experiencing the following prior to revision on (b)(6) 2019: effusion, numbness in feet at rest, and weakness.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: patient product x-ray images have been provided for review (alert dates: 31 mar 21 and 13 may 21).No device associated with this report was received for examination.Provided images are jpeg files within patient medical records.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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