Catalog Number SS8495 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Discomfort (2330); Joint Dislocation (2374); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2020 |
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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Patient was treated with a right shoulder prosthetics on the (b)(6) 2020 due to an unknown reason.During recovery the patient received a closed reduction to treat a pain and instability secondary to a dislocation caused by a fall.The recovery course has been complicated by a covid infection.The patient will be revised in (b)(6) 2021 after a nickel free implant is received due to the patient's nickel allergy.
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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: d4 (lot #) and d10 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1 and d4 (catalog).
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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.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture generalized disorder (e23).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).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: product/lot information is not available.
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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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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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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: d4 (procode,lot) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: examination of the returned device could not confirm the reported event, however wear was noted on the surface of the device.The investigation found no evidence of product malfunction or product error and the need for corrective action was not indicated.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.The investigation found no evidence of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Device history lot: a dhr review was conducted: 1) quantity manufactured: (b)(4).2) date of manufacture: manufacture commenced on the 25th aug 2020 and finished on 21st sept 2020.Product re-pack with patient specific labels commenced and completed on the (b)(6) 2020.Soc signature obtained on (b)(6) 2020.3) any anomalies or deviations identified in dhr: n/a (no re-works identified, all ctqs signed).4) expiry date: 2025-08 (as per the product label).5) ifu reference: (b)(4).(as per adaptiv).
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Search Alerts/Recalls
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