Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Naturally Worn (2988)
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Patient Problems
Foreign Body Reaction (1868); Test Result (2695); No Code Available (3191)
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Event Date 03/26/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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It was reported that no record of previous surgery was available and no lot information can be provided.Patient had pinnacle mom with a summit stem.Metal ion rates were elevated and surgeon planned to remove metal liner and head and replace with altrx liner and delta ts head.Surgery was performed uneventfully but surgeon noted that he believed the ion levels were likely from trunionosis from the stem head junction as that is where he could see wear and the bearing looked pristine in his opinion.Doi: (b)(6) 2020; dor: (b)(6) 2020; right hip.
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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 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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Manufacturer Narrative
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Product complaint # = > pc-(b)(4).Added: b5 corrected: d6 (additional information received that the date of implantation is unknown.).
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Event Description
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Additional information indicated that patient had a hip replacement at some time prior to (b)(6) 2020 where the sales representative does not know and when and what was placed.However, he do know that they took out a head, and a liner and replaced them on.
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Manufacturer Narrative
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Product complaint # (b)(4).New information has been added to h6 (patient codes).H6 patient code: no code available (3191) used to capture the device revision or replacement.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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Search Alerts/Recalls
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