Catalog Number 962713000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Scarring (2061); No Code Available (3191)
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Event Date 05/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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(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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The primary surgery was performed on (b)(6) 2010 via tha for the patient¿s right hip joint.It was reported that the revision surgery was performed on (b)(6) 2020 by replacing the liner (p/n: 121887354), the head (p/n: 962713000) and the stem (p/n: 900534210) due to suspicion of infection.Before the surgery, the pseudotumor was not found by x-rays, and the surgeon had a difficulty in judging whether there was infection although there was rising crp level.There was no anathema and redness around the primary surgery¿s incision.During the revision surgery, the surgeon found that the head and the neck-junction of the stem were black discolored and surrounding tissue was covered with scarring tissue.The revision surgery was completed, and it was unknown whether there was any surgical delay.The surgeon commented that this result was as per reported mom case, and it was expected result in consideration of the patient¿s high activity, sex (male) and mom.No further information is available.
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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.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.
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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.H6 patient code: no code available (3191) is used to capture device revision or replacement 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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Search Alerts/Recalls
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