DEPUY ORTHOPAEDICS INC US SROM*STM ST,30+4L NK,14X09X130; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Model Number 56-3514 |
Device Problem
Degraded (1153)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 04/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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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Medical records received.After review of medical records, the patient represent with increase pain and discomfort.Cobalt and chromium levels were elevated, a metal subtraction mri showed a large fluid collection, consisted with adverse tissue reaction.The patient was then revised for failed right metal on metal tha.Operative notes reported that there was about 60 cc of graying fluid emanated from what appeared to be a pseudotumor consistent with adverse tissue reaction.Some necrotic appearing material was debrided.There was some evidence of membrane formation at the metal interfaces consistent more with metal on metal reaction vs polyethylene osteolysis.There was a significant amount of blackish corrosion at the female portion of the femoral head.There was some corrosion on the taper.Doi: (b)(6) 2009; dor: (b)(6) 2019, right hip.
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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.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.A review of the device manufacturing records found no related deviation or anomalies.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.Device history lot: this manufacturing record (dhr) was reviewed previously.(b)(4), no related deviations or anomalies identified.Device history review: this manufacturing record (dhr) was reviewed previously.(b)(4), no related deviations or anomalies identified.H10 additional narrative: added: e3; corrected: e1.E3 initial reporter occupation: lawyer.
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