MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F1L; PREVIOUSLY SUBMITTED

Model Number NB014Z

Device Problems Fracture (1260); Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Clarification: on 19mar2020 additional information was received and 2 complaints were created for the patient, referencing the left knee arthroplasties.((b)(4)).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).

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)), ((b)(4)).The patient has also undergone multiple right knee revisions.

Event Description

No updates.

Manufacturer Narrative

Associated medwatch reports - referencing the left knee arthroplasties.(400469058) 2916714-2020-00094.(400469059) 2916714-2020-00102.Associated medwatch-reports: right knee arthroplasties 9610612-2019-00912 (400458621 nb018z); 9610612-2019-00913 (400458623 nr865z); 9610612-2019-00914 (400458624 nr295z); 9610612-2019-00916 (400458625 nr400z); 9610612-2019-00915 (400458626 nr882z); 9610612-2019-00917 (400458627 nb012z); 9610612-2019-01011 (400462509 nr192z) ; 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.

Manufacturer Narrative

Associated medwatch reports - referencing the left knee arthroplasties.(b)(6) 2916714-2020-00094; (b)(6) 2916714-2020-00102.Associated medwatch-reports: right knee arthroplasties: 9610612-2019-00912 ((b)(6)nb018z); 9610612-2019-00913 ((b)(6)nr865z); 9610612-2019-00914 ((b)(6) nr295z); 9610612-2019-00916 ((b)(6) nr400z); 9610612-2019-00915 (400458626 nr882z); 9610612-2019-00917 ((b)(6)nb012z).9610612-2019-01011 (400462509 nr192z) updated investigation: (right knee components) furthermore this case was discussed with several specialists from the development department and product management.Until there are no valid results from a laboratory investigation regarding tissue samples with the mentioned black staining, it is not possible to determine to origin of the discoloration of the soft tissue.In the meantime a telephone conference was held regarding the "the black staining" with specialists from the product management, an expert from r&d and the attending surgeon from usa.In this telephone conference was agreed that the provided explant components could be disassembled for further investigations.The idea is to separate the peek components for special investigation regarding unusual material abrasion/material inclusion.Due to the special corona situation at that time, this investigation is still outstanding.This 8 d report will be continuously updated with new information/ investigation results.A product safety case (psc) was opened.

Event Description

No updates.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F1L
• Type of Device: PREVIOUSLY SUBMITTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9935750
• MDR Text Key: 187421451
• Report Number: 2916714-2020-00094
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention