|
Model Number N/A |
Device Problems
Fracture (1260); Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
|
Patient Problems
Tissue Damage (2104); Osteolysis (2377)
|
Event Date 12/03/2015 |
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.Date of event - procedure has not yet occurred.Date explanted - device still implanted.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity.¿ this report is number 1 of 5 mdr's filed for the same event (reference 1825034-2015-04099 / 04262 / 04263 / 04264 / 04265).
|
|
Event Description
|
It was reported a bilateral patient underwent a left total hip arthroplasty on (b)(6) 1995 and a right total hip arthroplasty on (b)(6) 1990.Subsequently, operative notices indicate the patient underwent a right revision procedure on (b)(6) 1999 due to poly wear and dislocations.The acetabular cup was removed and a competitor cup was implanted.The patient was revised on (b)(6) 2000 for unknown reasons on an unknown side.The modular head was removed and replaced.On (b)(6) 2011 the patient dislocated on the right side and underwent a revision procedure.Operative notes report patient underwent a revision procedure on (b)(6) 2011 due to loosening of the cup, fractured screw, chronic dislocation, osteolysis, impingement, instability and soft tissue deficiencies.Operative report further noted the cup and head were removed and replaced during the revision procedure.A future revision has been indicated due to dislocations and a loose cup with a fractured screw.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
|
|
Event Description
|
It was reported a bilateral patient underwent a left total hip arthroplasty on (b)(6) 1995 and a right total hip arthroplasty on (b)(6) 1990.Subsequently, operative notices indicate the patient underwent a right revision procedure on (b)(6) 1999 due to poly wear and dislocations.The acetabular cup was removed and a competitor cup was implanted.The patient was revised on (b)(6) 2000 for unknown reasons on an unknown side.The modular head was removed and replaced.On (b)(6) 2011 the patient dislocated on the right side and underwent a revision procedure.Operative notes report patient underwent a right revision procedure on (b)(6) 2011 due to loosening of the cup, fractured screw, chronic dislocation, osteolysis, impingement, instability and soft tissue deficiencies.Operative report further noted the cup and head were removed and replaced during the revision procedure.A future revision has been indicated due to dislocations and a loose cup with a fractured screw.Additional information received reported patient was revised on (b)(6) 2015.
|
|
Search Alerts/Recalls
|
|
|