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

Model Number AE-QAS-K521-56

Device Problems Compatibility Problem (2960); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

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.It was reported that as a result of having the product implanted, the patient has experienced bilateral knee pain, difficulty walking, and loosening of the implants.The surgeon recommended revision surgery; however, at this time it has not yet occurred.The primary surgery occurred on (b)(6) 2013 (left knee).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).The following products were listed in the patient's medical records: primary surgery: left knee: nx011z (ps femur cemented f5n lt); 51946350, nx110 (ps pe insert t1/t1+, 10mm); 51949661, nx051z (ps tibia cemented t1); 51922285, nn260p (peek plug f/ tibia); 51967092, nx042 (universal patella p2); 51959433.Cement used during primary surgery: zimmer palacos r radiopaque bone cement.Associated medwatch report: 9610612-2020-00046 ((b)(4) ae-qas-k521-56) - right knee.

Manufacturer Narrative

General information: we received a complaint from (b)(6) hospital, 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).Associated medwatch reports: 9610612-2020-00046 ((b)(4) ae-qas-k521-56) - right knee; 9610612-2020-00047 ((b)(4) ae-qas-k521-56) - left knee.Consequences for the patient: post-operative medical intervention was necessary -> revision surgery investigation: no product at hand - therefore a failure description 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): primary surgery: left knee: nx011z (ps femur cemented f5n lt); 51946350; nx110 (ps pe insert t1/t1+, 10mm); 51949661; nx051z (ps tibia cemented t1); 51922285; nn260p (peek plug f/ tibia); 51967092; nx042 (universal patella p2); 51959433.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.Corrective action: a product safety case (psc) was opened.Any action regarding capa will be addressed with this case.

• Brand Name: COLLECT.NO.QAS KNEE IMPLANTS VEGA
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9800921
• MDR Text Key: 182557347
• Report Number: 9610612-2020-00047
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K101281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

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
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention