Catalog Number 121720500 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
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Event Date 03/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: (b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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(b)(4).Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant.Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(6) 2013) in which was implanted a pe/ceramic implant.Following this revision the patient accused pain and difficult in dehambulating.Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg./l update rec'd 27 april 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient has a loose acetabular component.At this time, the patients cup and screws are being reported for loosening.
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Manufacturer Narrative
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Examination of the reported devices was not possible as they were not returned.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy still 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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Depuy still 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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Event Description
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Update 20-apr-2017: medical records received.After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(6) 2014.Cup loosening was also mentioned in (b)(6) 2014.The patient was revised on (b)(6) 2015 for infection.All implants were removed and spacers were placed.Revision operative note wasn't provided so it¿s unknown if loosening and metallosis was found at revision.No labs were provided for the alleged high metal ion levels (labs were provided after the revision).Part/lot is being updated for the stem and the stem is now being reported.
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Manufacturer Narrative
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Depuy16-12.Patient in the year 2003 was subjected to a right hip arthroplasty in which received an asr implant.Due to mobilisation of the implant, the patient was subjected to a revision surgery ((b)(4) 2013) in which was implanted a pe/ceramic implant.Following this revision the patient accused pain and difficult in deambulating.Subsequent examination detected a mobilisation of the implants and metallosis with cr level ions of 04 microg./l update rec'd (b)(4) 2016 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient has a loose acetabular component.At this time, the patients cup and screws are being reported for loosening.The complaint was updated on: (b)(4) 2016.Update (b)(4) 2017: medical records received.After review of the medical records for mdr reportability, the medical records indicated a wound infection in (b)(4) and (b)(4) of 2014.Cup loosening was also mentioned in (b)(4) of 2014.The patient was revised on (b)(4) 2015 for infection.All implants were removed and spacers were placed.Revision operative note wasn't provided so it¿s unknown if loosening and metallosis was found at revision.No labs were provided for the alleged high metal ion levels (labs were provided after the revision).Part/lot is being updated for the stem and the stem is now being reported.This complaint was updated on: (b)(4) 2017.Update (b)(4) 2017: additional information received.Updated date of implant.This complaint was updated on (b)(4) 2017.Update (b)(4) 2017: additional information received.Updated date of implant.This complaint was updated on (b)(4) 2017.The reported event has been evaluated and will be monitored.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.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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