Catalog Number 999890245 |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
|
Patient Problems
Host-Tissue Reaction (1297); Erosion (1750); Cyst(s) (1800); Inflammation (1932); Pain (1994); Tissue Damage (2104); Weakness (2145); Anxiety (2328); Distress (2329); Discomfort (2330); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
|
Event Date 06/15/2017 |
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
|
Asr litigation received.Litigation alleges injury, pain, stiffness, discomfort, weakness, limited mobility, anxiety, emotional distress and elevated metal ion levels.Doi: (b)(6) 2008; dor: (b)(6) 2017; right hip.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint #: (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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
|
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 records, the patient was revised due to right total hip arthroplasty failure secondary to adverse local soft tissue reaction and cystic mass.It was also confirmed that patient had elevated metal levels.Revision notes stated that patient had an erosion in the mid portion of the junction of the it band, soft tissue destruction, inflammed and hypertrophied synovium, and necrosis, bone loss, osteolysis there was very little corrosion on stem and sleeve interface, majority of the corrosion was between the sleeve and the head.
|
|
Search Alerts/Recalls
|