MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS VEGA; PREVIOUSLY REPORTED

Model Number AE-QAS-K521-56

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with knee implants vega.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 (left), 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: 9610612-2020-00044 ((b)(4) collect.No.Qas knee implants vega)- right the following products were listed in the patient's medical records: left knee: nx011z (ps femur cemented f5n lt); 51964473, nx130 (ps pe insert t3/t3+, 10mm); 51999673, nx055z (ps tibia cemented t3); 51991156, nx042 (universal patella p2); 51971942, nx063z (tibial stem cemented 14x52mm); 51650361.Cement used during primary surgery: left knee: smith & nephew versabond cement.

Manufacturer Narrative

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.

Event Description

No updates.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9800447
• MDR Text Key: 182534695
• Report Number: 2916714-2020-00062
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-K521-56
• Device Catalogue Number: AE-QAS-K521-56
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention