Model Number 1570-11-120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Blood Loss (2597); Test Result (2695); No Code Available (3191)
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Event Date 03/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.Additional follow up is being conducted to determine the initial reporter.If/when additional information is received, a supplemental 3500a will be submitted.(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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Unf and medical records received.Pinnacle claim submission form alleges elevated metal ions and infection.After review of medical records patient was revised to address metal on metal right hip arthroplasty with pinnacle cup and metal liner and summit stem with cobalt chrome head and infection reaction due to prosthetic device right tha.Revision notes reported that the cultures were obtained at this time.Anerobic aerobic afb and fungal and a gram stain.Doi: (b)(6) 2009, dor: (b)(6) 2019 (right hip).
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Event Description
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Additional information received stated that the patient presented with right hip pain in the groin area as well as in the trochanteric bursa region.During clinic visit on (b)(6) 2019.
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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.Patient code: retracting code for hemorrhage and blood loss and replaced with pain.
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Search Alerts/Recalls
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