Model Number 1504-10-206 |
Device Problem
Migration (4003)
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Patient Problems
Adhesion(s) (1695); Fall (1848); Pain (1994); Joint Laxity (4526)
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Event Date 01/04/2019 |
Event Type
Injury
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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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Event Description
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Initial report: the patient was revised to address loosening of the tibial and femoral components at the bone to cement interface.Cement manufacturer is unknown.Revised patient's knee subsequent to a fall.The trauma caused proximal tibia fracture and instability.Doi: unknown.Dor: (b)(6) 2019.Right knee.Medical records received and provide the following information: primary operative notes (b)(6) 2015 indicate the patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized x2.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2019 indicate the patient received a right total knee revision due to pain and subsidence of the tibial and femoral components.Notes indicate the patient was experiencing pain prior to a recent fall but the pain increased significantly post fall and led her to be seen by her doctor.Upon entering the joint, significant adhesions were encountered and removed.Tibia and femoral components were noted to be loose and revised along with the insert.Patella remained implanted with no indication of deficiency.The surgery was completed without indication of complication by the surgeon.
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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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