Catalog Number 155401121 |
Device Problems
Corroded (1131); Degraded (1153); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 02/05/2018 |
Event Type
Injury
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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.This complaint is the subject of litigation or a legal claim and complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Litigation papers allege corrosion and friction wear is believed to have caused amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's tissue surrounding the implants.As a result, the patient has been experiencing severe pain and difficulty with her implants.The patient has experienced severe pain and discomfort and inflammation in both of her thigh and hip areas.She also feels extreme discomfort when walking.Blood testing indicated that the patient's cobalt and chromium levels are elevated.She is expected to undergo revision surgeries to remove the devices in both hips.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot codes were not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed.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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(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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Event Description
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Update 4/15/16- pfs and medical records received.Pfs and medical records reviewed for mdr reportability.Pfs reported pain, decreased mobility, weakness, difficulty walking and standing, walk with limp, swelling, elevated metal ions, unable to do activities of daily living and constant headaches for 9 months.Medical records reported bilateral crepitus, decreased mobility, difficulty sleeping, grinding, joint pain, limping, locking, popping, stiffness, tenderness and weakness with right greater than left.Metal ion lab results reported chromium greater than 7 parts per billion.No revision surgical report or report of revision surgery completed.Mars mri reported fluid collection consistent with alval.Part/lot updated.The complaint was updated on: may 4, 2016.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and/or liner.Per procedure, this device(s) is exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been 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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Ppf alleges metallosis.
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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. .
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Event Description
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After review of medical records, patient was revised due to failed hip arthroplasty.Operative findings indicated metallosis, soft tissue destruction and trunionosis.
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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.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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