MAUDE Adverse Event Report: AESCULAP AG AS UNIVATION XF TIBIA CEMENTED T1 LM; KNEE ENDOPROSTHESES

Model Number NO162Z

Device Problem Mechanical Problem (1384)

Patient Problem Arthritis (1723)

Event Date 04/03/2020

Event Type  Injury  

Manufacturer Narrative

Upon review of the investigation an additional component was added and reported.Leading components: nl470 - univation f meniscal comp.T1 rm/lm 7mm - 52342314.No186z - as univation xf femur cemented f2 lm - 52349056.Involved components: no162z - as univation xf tibia cemented t1 lm - 51981147.Investigation results: up to date of this report, the complained devices are not available for investigation.The following information was provided: 1y po rev.- abraded coating was found.Revision was performed after about 12 months due to lateral arthrosis.According to the surgeon's statement, the as coating has worn off in the area of the loading zones.This would now be clearly visible in the pe inlay.The user provided several figures to us.The discoloration of the as coating according to the provided figures could be oxidation (the discoloration is typical for oxidation).The meniscal component is aged independently from the other components -> gliding surface absorbs environment liquid from the patient, this lead to the discoloration.The device quality and manufacturing history records have been checked for all available lot numbers (52342314, 52349056 and 51981147) 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.Based on the information available it is not possible to determine a definitive root cause for the situation.The mentioned situation is probably not product related.It could be possible that the discoloration (meniscal component) is patient related.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.The mentioned situation is no failure in the proper meaning.Due to the circumstances that it is not possible to determine a definitive root cause for this failure the risk analysis is not applicable.A capa is not necessary.

Event Description

At first this medwatch is a additional formal late notification of the component involved.Involved component already submitted with the notifications 9610612-2020-00154 (400470714 - nl470) and 9610612-2020-00158 (400470721 - no186z).It was reported that there was an issue with product as univation xf tibia cemented t1 lm.According to complaint description it was reported that a revision surgery was performed after about 12 months due to lateral arthrosis.According to the surgeon's statement, the as coating has worn off in the area of the loading zones.This would now be clearly visible in the pe inlay.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00154 (400470714 - nl470).9610612-2020-00158 (400470721 - no186z).

Event Description

Associated medwatch-reports: 9610612-2020-00154 (400470714 - nl470); 9610612-2020-00158 (400470721 - no186z).Involved components: no162zas - univation xf tibia cemented t1 lm - batch 51981147.

Manufacturer Narrative

Leading components: nl470 - univation f meniscal comp.T1 rm/lm 7mm - 52342314; no186z - as univation xf femur cemented f2 lm - 52349056.Involved components: no162z - as univation xf tibia cemented t1 lm - 51981147.General information: we received a complaint regarding a nl470 to univation f meniscal comp.T1 rm/lm 7mm and a no186z to as univation xf femur cemented f2 lm from the diakonie klinikum, neubrandenburg, germany.In the meantime the complained devices are available for investigation.Investigation: preliminary assessment from the product management and the biomechanical department, based on the provided pictures: the discoloration of the as coating could be oxidation (the discoloration is typical for oxidation).The meniscal component is aged independently from the other components to gliding surface absorbs environment liquid from the patient, this lead to the discoloration.As mentioned under point general information: in the meantime the complained products are available for investigation.The components were examined visually and microscopically with the digital microscope vhx-5000 keyence eq.-nr.2000024840 and the digital-camera "panasonic dmc tz8".The complained devices were inspected together with a specialist from the product management: the femoral component shows visible discoloration at the gliding surface.The gliding surface of the meniscal component shows almost no color change in contrast to the provided figure.Result: the mentioned discoloration is no abrasion of the coated surface.Rather it is a result of oxidation.The as multilayer coating can undergo changes to the surface color.Such changes in color have no effect on the function or properties of the coating.This is also mentioned in the ifu.In conclusion can be noted that the preliminary assessment has been confirmed.Batch history review: the device quality and manufacturing history records have been checked for all available.Lot numbers 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 as well as a result of our investigation there is no product failure.Rationale: there is no indication for a material defect or manufacturing failure.The mentioned situation is no failure in the proper meaning investigation.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: AS UNIVATION XF TIBIA CEMENTED T1 LM
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10123268
• MDR Text Key: 195723996
• Report Number: 9610612-2020-00212
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K131167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: NO162Z
• Device Catalogue Number: NO162Z
• Device Lot Number: 51981147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR