Catalog Number 121725500 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003); Insufficient Information (3190)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 03/10/2014 |
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 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 alleges the patient suffers from pain, swelling, inflammation and infection.Update rec'd (b)(6) 2014 - pfs and medical records received.Part/lot information provided.A correct doi and dor was provided.After review of the medical records the patient had a poly liner implanted so the other implants besides the head and liner cannot be excluded as the cause the pain.All other implants are being added to the complaint.There is no new additional information that would affect the existing mdr decision.The complaint was updated on:.
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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 still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
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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 finds no other related or similar reports against the provided product/lot code combinations since their release to distribution.Primary bi-lateral implantation medical records were received.No notes regarding the reported infection provided.No revision operative notes provided.No conclusions can be drawn from review of provided medical records.The patient was primarily implanted on the left side in (b)(6) 2009 and revised for infection and subsequent pain, swelling and inflammation in (b)(6) 2012.It is not likely or reasonable to conclude the depuy devices contributed to the patient's reported infection almost three years post primary implantation.The patient is a reported (b)(6) male with a 52.0 bmi.The patient is morbidly obese.It is stated in the warnings and precautions that excessive patient weight tends to adversely affect hip replacement implants.The investigation can draw no conclusions with the information provided.Product problem has not been identified based on the inability to determine root cause, the need for corrective action has not been 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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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 caused or contributed to the potential event described in this report.
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Event Description
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Ppf alleges dislocation (open and closed reduction).After review of medical records, it was stated that the patient was revised to address asceptic loosening of the femoral component; however, loosening interface was not specified.Revision notes reported significant loosening of femoral component with subsidence; and there was moderate acetabular wear but no loosening.There was no confirmed dislocation and infection.It was inidcated that depuy acetabular components were implanted but the new femoral components were non-depuy.Added account name.Corrected weight of patient.Updated patient harm.Doi: (b)(6) 2009, dor: (b)(6) 2012 left 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 caused or contributed to the potential event described in this report.Udi: (b)(4).Patient code: no code available (3191) used to capture the medical device removal and blood heavy metal increased.
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Event Description
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Ppf alleges loosening of cup and stem, metal wear, metallosis and elevated metal ions.
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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.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.H10 additional narrative: corrected: h6 (device).
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Search Alerts/Recalls
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