Model Number 5450-31-500 |
Device Problems
Loss of or Failure to Bond (1068); Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Fatigue (1849); Weakness (2145); No Code Available (3191); Joint Laxity (4526); Muscle/Tendon Damage (4532)
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Event Date 09/11/2019 |
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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Clinical adverse event received for ruptured patellar tendon: tendon rupture event is serious and is considered severe.Event is definitely related to both device and there is a remote possibility it is related to procedure.
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Manufacturer Narrative
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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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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.Additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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: null.Device history batch: null.Device history review: null.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).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: h6 patient code: no code available (3191) was used to capture joint instability, tendon rupture and surgical intervention.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 - no device associated with this report was received for examination.Review of the x-ray evidence found nothing indicative of a device nonconformance or anything indicative of a contribution to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - device history reviewed on (b)(6) 20 1 unrelated non-conformances on this lot number.Final micro and sterility tests passed.2740 units released.Lot expiry date: (b)(6) 21 there were no anomalies in manufactuiring that related to the reported event.Device history review - a manufacturing record evaluation was performed for the finished device [(b)(4)] number, and no non-conformances / manufacturing irregularities were identified.Added: d6a, d6b, h6 (impact, clinical and problem code) d2b, g4.
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Search Alerts/Recalls
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