It was reported that there was an issue with vega knee implants.According to the customer description: it was reported that as a result of having the products implanted, the patient has experienced bilateral knee pain and a loss of mobility.The primary surgery occurred (b)(6) 2014 (right), and there was no reported revision surgery.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.The adverse event/malfunction is filed under (b)(4).Associated medwatch report: 9610612-2020-00045 ((b)(4) ae-qas-k521-56) - left knee.The following products were listed in the patient's medical records: nx131 (ps pe insert t3/t3+, 12mm); 52005865, nx055z (ps tibia cemented t3); 51800603, nx031z (ps femur cemented f5n rt); 51931511, nx063z (tibial stem cemented 14x52mm); 51995042, nx043 (universal patella p3); 52010677.Cement used during primary surgery: right knee: smith & nephew versabond cement.
|
The following products were listed in the patient's medical records: nx131 (ps pe insert t3/t3+, 12mm); 52005865 nx055z (ps tibia cemented t3); 51800603 nx031z (ps femur cemented f5n rt); 51931511 nx063z (tibial stem cemented 14x52mm); 51995042 nx043 (universal patella p3); 52010677.General information we received a complaint from the baton rouge general medical ctr, baton rouge, regarding vega components.There are no devices available for investigation.We do not know exactly the reference code, as well as the batch number of the leading and involved components.There are no x-ray figures available.This case is in relation to case (b)(4) same patient, other knee).Consequences for the patient permanent damage to body.Investigation no product at hand - therefore an investigation is not possible.Batch history review a review of the device quality and manufacturing history records is not possible because the material number as well as the batch number is unknown.The device quality and manufacturing history has been checked for the mentioned components (up to now there is no clear evidence that this devices were used): nx131 (ps pe insert t3/t3+, 12mm); 52005865 nx055z (ps tibia cemented t3); 51800603 nx031z (ps femur cemented f5n rt); 51931511 nx063z (tibial stem cemented 14x52mm); 51995042 nx043 (universal patella p3); 52010677.And found to be according to our specification valid at the time of production.No similar incidents have been filed with products from these batches.Conclusion and root cause based on the information available it is not possible to determine a possible root cause for the failure.Rationale in the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Based on the problem description we assume that this case falls into the theme: implant loosening.Corrective action a product safety case (psc) was opened.Any action regarding capa will be addressed with this case.
|