Model Number 1217-20-052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Erythema (1840); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
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Event Date 03/24/2021 |
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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Post-op inflammation.This case is from health authority.It was reported that the patient underwent a left hip arthroplasty for osteonecrosis of the left femur and was discharged 6 days after surgery.On the 16th day after operation, the wound of left buttock suffered from erythema, inflammation, heat and pain when the patient performed self-compress at home.On the 35th day after the operation, the patient was hospitalized again.Local subcutaneous tissue incision, drainage were performed.Dressing change and antibacterial treatment were given.After 41 days, the local erythema, inflammation, heat and pain and exudation of the wound disappeared.The patient was discharged.About 4 and half months later, the original incision site appeared mass and pain.The patient was hospitalized for the third time.No additional information could be provided.
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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.H10 additional narrative: 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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Additional information received indicated that the patient was discharged 6 days after the implantation.16 days after the surgery, the patient suffered from erythema, inflammation and pain, heat.On (b)(6), local redness, swelling, heat pain and wound exudation disappeared and discharged.On (b)(6), mass and pain occurred again in the original incision and the patient was hospitalized for the third time.Affected side was the left side.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: device associated with this report was not received for examination, however x-ray photos were provided.All available x-rays were reviewed, and it can't be determine any device related problem.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a worldwide complaint database search found no additional previous reports against the provided product code/lot code combination.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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