Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.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.
|
On (b)(6) 2022, 14 days post-op from revision, patient demonstrates a small area of erythema on the medial aspect of the incision distally.Patient prescribed bactrim for 10 days.On (b)(6) 2022, patient falls the previous day and lands on her left side.The right knee continues to do well but has 1+ effusion.She demonstrates a 10 degree extensor lag with straight leg raise.On (b)(6) 2023, patient complained of joint pain, stiffness, and swelling.She states her right knee buckles and gives way.She cannot walk up/down stairs normally.Doi: (b)(6) 2022; doe: (b)(6) 2022; right knee.
|