Patient was revised to address instability.It was noted, the patient fell.Updated rec'vd 9/14/2016- clinical der states patient was revised to address instability.There is no new information at this time that would change the current mdr decision.Clinical information and comorbidities will be added to complaint.The complaint was updated on 9/18/2016.Update rec'd 9/21/2016: medical records received.After review of the medical records for mdr reportability, the medical records indicated the patient had pain, swelling, and instability before the dor.Patient did sustain a fall in (b)(6) 2015.Diagnostic imaging indicated no findings (loosening, osteolysis, or malpositioning).The patient indicated the patella was grinding, locking, and shifting.The patella wasn't revised on (b)(6) 2016.Depuy cement was used during the primary.All products are now being reported.This complaint was updated on: 10/14/2016.
|
No device associated with this report was received for examination.A complaint database search on the provided smartset mv 40g - eo (product 3122040, lot number 3623617) found an additional report and a dhr review was conducted.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number (3623617).Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
|