Catalog Number 999890247 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Scar Tissue (2060); Weakness (2145); No Information (3190); No Code Available (3191)
|
Event Date 03/23/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Complete product detail has not been received at this time.If further information is received a follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Aug 8, 2017: litigation records received.Litgation alleges high concentrations of various metallic elements in the patient's blood.
|
|
Manufacturer Narrative
|
Additional narrative: no device associated with this report was received for examination.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.
|
|
Manufacturer Narrative
|
Litigation records received.Litigation alleges high concentrations of various metallic elements in the patient's blood.The reported event has been evaluated and will be monitored.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
After review of medical record, it was stated that the patient was revised to address metallosis and aseptic loosening of the acetabular component.Pain, weakness and disability were also noted.Revision notes reported that a scar tissues were removed and there was no bone ingrowth in the porous coating of the shell.Doi: (b)(6) 2009.(b)(6) 2017.Right hip.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).
|
|
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).The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- 001226.Ongoing post market surveillance is conducted per our procedures for this product.Device history lot = null.Device history batch = null.Device history review = null.Investigation results have been incorporated in the finalized medwatch.
|
|
Search Alerts/Recalls
|