Catalog Number UNK-HIP |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Cyst(s) (1800); Pain (1994); Swelling (2091); Weakness (2145); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 09/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.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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Litigation record received.Litigation alleges dislocation and pain.It was noted during revision that a cystic-like mass at the anterior acetabulum that extended all the way down to the hip joint itself and was full of greenish fluid.
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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 code(s) was 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.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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Event Description
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In addition to what was previously alleged, pfs also alleges adverse reaction to anesthesia, bone damage & bone loss, swelling, loss of mobility, difficulty walking, extreme fatigue, hip weakness reduced mobility and endurance.After the review of medical records for mdr reportability, it was stated that the patient was revised to address right hip dislocation.Revision notes reported mass with cystic like structure, greenish fluid but negative for infection, and an anteverted acetabulum.
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Manufacturer Narrative
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No device associated with this report was received for examination.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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