|
Model Number N/A |
Device Problems
Corroded (1131); Material Fragmentation (1261)
|
Patient Problems
Cyst(s) (1800); Neuropathy (1983); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Osteolysis (2377); Ambulation Difficulties (2544)
|
Event Date 10/23/2013 |
Event Type
Injury
|
Manufacturer Narrative
|
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿damage to blood vessels, hematoma, delayed wound healing and/or infection.¿ number 5 states, ¿temporary or permanent nerve damage may result in pain and numbness.¿ number 6 states, ¿material sensitivity reactions.¿ number 10 states, ¿periarticular calcification or ossification, with or without impediment of joint mobility.¿ number 15 states, ¿fretting and crevice corrosion can occur between components.¿ this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2014-07762).
|
|
Event Description
|
Patient reported a right total hip arthroplasty was performed (b)(6) 1999.Patient alleges difficulty walking/climbing, lump on hip with metal fragments, peripheral neuropathy, and bone/muscle loss and damage.Subsequently, medical records reveal patient was revised on (b)(6) 2013 due to a cystic mass and osteolysis of greater trochanter.The patient¿s operative report noted corrosion at taper adapter junction, swelling, possible reactive synovitis, cystic material, cloudy brown-colored fluid, caseous brown material, brown staining material, osteolysis, and necrotic tissue.The patient¿s operative report also noted that all biomet components were removed and replaced with competitor products during the revision procedure.This report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.
|
|
Search Alerts/Recalls
|
|
|