Catalog Number 121887350 |
Device Problems
Corroded (1131); Difficult to Remove (1528)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Tissue Damage (2104); Weakness (2145); Test Result (2695); No Code Available (3191)
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Event Date 01/28/2019 |
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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Unf and medical records received.There were no allegation reported from unf.After review of medical records, patient was revised to address right hip adverse local tissue reaction due to metal on metal total hip replacement.Indication note reported weakness, cobalt level 140 and chromium level 100, and on x-ray there was protrusion of the shell.Operative note reported significant amount of necrotic tissue that had corrosion, abductor tissue loss, and there was corrosion on the taper, corrosion at the edge of the shell and liner, and the liner appeared cold welded to the shell, bone loss from the shell removal, pseudotumor and cysts.Doi: (b)(6) 2008; dor: (b)(6) 2019; (right hip) first revision.
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Manufacturer Narrative
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Product complaint # (b)(4).Duplicate event found in mfr# 1818910-2019-84882.Additional information previously reported in 1818910-2019-84882 is being incorporated 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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Event Description
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It was reported that the dr texted the sales rep and said "i have a metal on metal revision hip coming up i wanted to see what my headliner options were".After a brief phone call, the surgeon decided that he was going to try to preserve the cup, remove the metal liner and preoperative plan was to trial and replace liner with +4/10° and +9 32mm head.Dr.Could not remove metal liner using a ab extractor, reciprocating saw, and bone tamps.Dr.Decided to remove entire cut implant zimmer acetabular cup and liner and also implant +5 ts 32 mm head.Nothing was said about the metal on metal liner but there was an obvious understanding that it was an issue based on the explant and tissue surrounding the cup.There was a surgical delay of 1 hour and 30 mins.Doi: (b)(6) 2008; dor: (b)(6) 2019'; right hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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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Search Alerts/Recalls
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