Model Number 5450-35-500 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problems
Edema (1820); Muscular Rigidity (1968); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 05/14/2018 |
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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Depuy sigma litigation record received.Litigation record alleges pain,discomfort, instability,difficulty ambulating, caused by aseptic loosening of smartset ghv bone cement.Doi: (b)(6) 2014.Dor: not reported; left knee.
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Event Description
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Medical records received and were reviewed: the depuy patellar component was retained during the left knee revision on (b)(6) 2018.Following the revision, the patient was noted to be experiencing the following adverse symptoms on various dates: pain, stiffness, and swelling.There is no evidence of a second revision nor invasive treatment to address the indicated symptoms involving the retained depuy patellar component and competitor products.
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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 : the device associated with this report was not returned to depuy synthes for evaluation.The photo and x-ray investigation found nothing indicative of a device nonconformance or loosening.To confirm the allegation a series of chronological x-rays is needed, therefore the reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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