Model Number 96-0014 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Hemorrhage/Bleeding (1888); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526)
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Event Date 12/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Clinical adverse event received for stiffness and hemarthrosis.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: (b)(6) 2015.Date of event: (b)(6) 2022.(right knee).Treatment: aspiration of 10ml of bloody fluid, sent for synovasure.
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Event Description
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On (b)(6) 2015, the patient had a right cemented total arthroplasty to address osteoarthritis, end-stage, secondary to previous acl reconstruction.Depuy components, including depuy patella were utilized during this procedure.On (b)(6) 2022 medical records note the patient had a previous fall, in which he hyperflexed his knee.The patient has been experiencing stiffness, pain, and limited range of motion.On (b)(6) 2022 phone record notes the patient has struggled with increasing pain and stiffness.
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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: added: b5, h6 (clinical codes) 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Through follow up it is now understood there is no allegation associated against a product malfunction.Nothing indicative of a device nonconformance was found.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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