Catalog Number 136553000 |
Device Problems
Failure to Align (2522); Insufficient Information (3190)
|
Patient Problems
Inflammation (1932); Pain (1994); Injury (2348); Joint Swelling (2356); Ambulation Difficulties (2544)
|
Event Date 10/18/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
|
|
Event Description
|
Oct 18, 2017: litigation record received.Litigation alleges pain.There is no report of revision at this time.
|
|
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.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.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
In addition to what was previously alleged, pfs alleges walking difficulty and left leg is approximately 35 degrees turned to left out of line on the right leg.After the review of medical records, it was reported that had bursitis.There was no reported revision.Added new associated contacts.
|
|
Manufacturer Narrative
|
(b)(4).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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .
|
|
Search Alerts/Recalls
|