Model Number 1219-32-254 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Joint Dislocation (2374); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 09/18/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Clinical notification received for revision of left total hip to address aseptic loosening and adverse local tissue reaction.Date of implantation: (b)(6) 2008, date of revision: (b)(6) 2020.Treatment: femoral stem, femoral head, and acetabular liner revised.
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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.No code available ((b)(4)) is used to capture joint instability and limb asymmetry 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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Event Description
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On (b)(6) 2020, the patient underwent a second left hip revision due to pain, instability, stiffness, arthrofibrosis, metallosis, inflammation, edema, difficulty walking, limb asymmetry, and a loose and migrated femoral stem.The surgeon also noted placing a constrained liner due to multiple dislocations following the first revision.There is no evidence of prior treatment for the dislocations.The cup was retained during the revision.
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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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Event Description
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The surgeon noted placing a constrained liner due to multiple dislocations following the first revision.
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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.
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Search Alerts/Recalls
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