Catalog Number UNK-KNEE |
Device Problem
Naturally Worn (2988)
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Patient Problems
Pain (1994); Swelling (2091); Osteolysis (2377)
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Event Date 07/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Depuy synthes has been informed that the catalog number and lot number is not available.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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Patient was revised to address poly wear and osteolysis.Update rec'd 07/28/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient was revised to address pain, swelling, and effusions.The tibial insert and patella are being reported at this time.The complaint was updated on: 08/13/2015.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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