Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Scarring (2061); Tissue Damage (2104); Test Result (2695); No Code Available (3191)
|
Event Date 04/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
Pinnacle claim submission form and medical record received.After review of medical records received, patient was revised to address metallosis and septic joint or prosthetic joint infection and pain.Operative notes reported yellow purulent material possible for infection and metallosis due to metal implant and a scarred looking tissue.Lab results show elevated cobalt metal ions in the blood.Doi: (b)(6) 2008; dor: (b)(6) 2019; left hip.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.H10 additional narrative: 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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|