Model Number 1365-53-000 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Cyst(s) (1800); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
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Event Date 08/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Unf and medical records received.After review of medical records, the patient was complaining of hip pain, then the patient for adverse local tissue reaction of right metal-on-metal total hip arthroplasty.Operative findings reported that there is a large amount of straw-colored fluid of approximately 8 ml that was aspirated.On entry into the deep fascia, there was overall large pseudotumor formation.There is a large amount of fatty infiltrate along her posterior capsule insertions.There is loss of abductors of at least 25% of the gluteus minimus.There is a large cystic formation anterior and anterolateral along her proximal femur.There is necrotic debris in the cystic formation.When the femoral head was removed, there is a small ring of black precipitate on the cobalt chrome head.It should be noted that the stem is also cobalt.So, again significant loss of soft tissue structures with fatty infiltrate along posterior necrosis and fatty infiltrate along the abductors and a large cystic formation anteriorly with loss of abductors, quadriceps, and anterior structures.Doi: (b)(6) 2007; dor: (b)(6) 2018; right 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 that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.Device history lot : null device history batch : null device history review : null 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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