Model Number 62-3401R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abscess (1690); Joint Dislocation (2374); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 12/30/2010 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
Clinical adverse event received for vascular compromise with subsequent compartment syndrome and grafting : infection - deep.Event is serious and is considered severe.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2004, date of event (onset): (b)(6) 2010, (right knee).Treatment: revised on (b)(6) 2011, all products explanted.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
|
|
Event Description
|
On (b)(6) 2004, the patient underwent a bilateral knee arthroplasty due to arthritis.Depuy products were implanted in both knees.There were no indicated intra-operative complications.On (b)(6) 2011, the patient underwent a right knee revision to address infection, compartment syndrome, dislocation, instability, and abscess.All components were noted to be removed and replaced with articulating antibiotic spacer.Unknown manufacturer products were implanted during the revision.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|