MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1L; KNEE ENDOPROSTHESES

Model Number NB014Z

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

On 19mar2020 additional information was received and 2 complaints were created for the patient, referencing the left knee arthroplasties.(b)(4), 9610612-2020-00134.Associated medwatch-reports: right knee arthroplasties 9610612-2019-00912 ((b)(4) nb018z), 9610612-2019-00913 ((b)(4) nr865z), 9610612-2019-00914 ((b)(4) nr295z), 9610612-2019-00916 ((b)(4) nr400z), 9610612-2019-00915 ((b)(4) nr882z), 9610612-2019-00917 ((b)(4) nb012z), 9610612-2019-01011 ((b)(4) nr192z).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.Right knee investigations ongoing, reported separately.A product safety case (psc) was opened.

Event Description

It was reported that there was an issue with enduro components.On (b)(6) 2014 the patient underwent a left total knee revision replacement; enduro implants were used and palacos cement.It was noted that a non-aesculap device was removed at that time.On (b)(6) 2015, the patient had left total knee arthroplasty (tka) for distal femoral peri-prosthetic fracture with loosening.The implants were replaced with enduro devices.Components were cemented one-on-one with tobramycin.On (b)(6) 2019, there was tibial and femoral loosening which required revision.A niobium-coated implant was used instead.Black staining of the tissues was noted.Additional treatments included stimulan pellets and vancomycin.Additional information has been requested.Associated medwatches: (b)(4), 9610612-2020-00134.The patient has also undergone multiple right knee revisions.

Manufacturer Narrative

Associated medwatch-reports: right left arthroplasties: (400469058) 9610612-2020-00133 (400469059) 9610612-2020-00134.Associated medwatch-reports: right knee arthroplasties 9610612-2019-00912 (b)(4).9610612-2019-00913 (b)(4).9610612-2019-00914 (b)(4).9610612-2019-00916 (b)(4).9610612-2019-00915 (b)(4).9610612-2019-00917 (b)(4).9610612-2019-01011 (b)(4).Updated investigation: (left knee).Failure description no product at hand, therefore a failure description is not possible.Batch history review the traceability of articles with batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause based on the information available it is not possible to determine a definitive root cause for the failure.At that time we do not consider that the mentioned failure is product related.Rationale until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine the origin of the discoloration of the soft tissue.It is therefore not possible to determine a definitive root cause for the mentioned black staining.Corrective action a product safety case (psc) was opened.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F1L
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9958860
• MDR Text Key: 188675180
• Report Number: 9610612-2020-00133
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB014Z
• Device Catalogue Number: NB014Z
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention