Catalog Number 157001120 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); No Code Available (3191)
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Event Date 12/16/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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 revised to address pain and "popping" feeling at times.Malpositioned cup noted with chromium and cobalt levels 46.9 and 130.1, respectively.
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Manufacturer Narrative
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Patient was revised to address pain and "popping" feeling at times.Malpositioned cup noted with chromium and cobalt levels 46.9 and 130.1, respectively.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.The investigation can draw no conclusion with the information provided.Based on the inability to determine a root cause, the need for corrective action has not been identified.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.
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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.Product complaint # = > (b)(4).Investigation summary = > 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.Depuy considers the investigation closed.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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Event Description
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Ppf alleges metal wear and metallosis.Added lawyer, law firm, dob, revision hospital, updated patient harms and updated product details in ips.Corrected doi and patient identifier.
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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. udi: (b)(4).
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Search Alerts/Recalls
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