As of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that there are 10 similar complaints against the same lot number(s).Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results there is capa is not necessary.
|
It was reported that there was an issue with vega ps tibial plateau.According to the complaint description that as a result of having the product implanted, the patient has experienced pain, difficulty walking, and loosening of the implant.The primary surgery occurred on (b)(6) 2013 and the revision surgery occurred on (b)(6) 2018.Primary surgery: (b)(6) 2013.Revision surgery: (b)(6) 2018.A revision surgery was necessary.All available information has been provided at this time, if additional information becomes available the report will be updated accordingly.The adverse event is filed under aag reference (b)(4).Involved components: nx132 - vega ps gliding surface t3/3+ 14mm - lot 51949663, nn260p - plug f/tibial plateau - lot 51974495, nx013z - as vega ps femoral comp.Cemented f6n l - lot 51927043, nx044 - patella 3-pegs p4 - lot51911583, cement used is unidentified.
|