Catalog Number 157001110 |
Device Problems
Corroded (1131); Material Disintegration (1177); Insufficient Information (3190); Noise, Audible (3273)
|
Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); No Code Available (3191)
|
Event Type
malfunction
|
Event Description
|
New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint ¿ litigation papers allege that corrosion and friction wear caused large amounts of toxic cobalt-chromium metal ions and particles to be released into the patient's blood and tissue and bone surrounding the implant.It is further alleged that the patient has experienced severe pain and discomfort and inflammation in his right thigh and hip area, as well as his groin.Patient has experienced episodes of a grinding and popping sensation in his right hip.Update 1/30/15 - (b)(4) pfs and medical records received.Pfs identified patient dob, dor, height and weight.The unknown hip is being changed to an unknown liner and an unknown head and stem are being added to address previous allegations.
|
|
Manufacturer Narrative
|
Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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 additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|
|
Event Description
|
Ppf has no new allegation.
|
|
Manufacturer Narrative
|
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|