Model Number 1365-52-100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994); Pocket Erosion (2013); Impaired Healing (2378); Swelling/ Edema (4577)
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Event Date 04/17/2019 |
Event Type
Injury
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Event Description
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Unfiled claim and pinnacle mom medical records received.After review of the medical records the patient was revised to address pain and failure of mechanical right total hip arthroplasty.Operative findings suggestion of trochanteric bursitis without presence of pseudotumor.Operative note reported some attenuation in the fascia right trochanter.Previous abductor repair not completely healed, there was new erosion and large amount of fluid.Pathology report evidence of trochanteric bursitis.Doi: (b)(6) 2011; dor: (b)(6) 2019; right hip.
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Manufacturer Narrative
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Product complaint # (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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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.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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