Model Number 1217-32-052 |
Device Problems
Product Quality Problem (1506); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
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Patient Problem
Not Applicable (3189)
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Event Date 06/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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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It was reported that the handle stuck to cup.They had to use new cup and different handle.Surgical delay of 3 minutes.
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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Investigation summary = > examination of the returned device was unable to confirm the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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).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).Investigation summary: examination of the returned device was unable to confirm the complaint.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory 228 reported that the handle stuck to cup.Examination of the device was unable to confirm the complaint.A functional check with a mating impactor found the device to function as intended.The root cause appears to be undetermined with no product problem identified.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Based on the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Continue to monitor complaints under post market surveillance (b)(4).Device history lot: examination of the device was unable to confirm the complaint.Mre not performed.
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Search Alerts/Recalls
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