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Model Number NB015K
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
Height: 162cm. Investigation: the components have been examined visually and microscopically. The external screw thread of the rotation axis show visible damages/material abrasions on the whole circumference. Furthermore the taper of the rotation axis shows visible damages. The distal end of the inner thread of the rotation axis locknut shows damages. There are little metal inclusions on the gliding surface of the meniscal component. Batch history review: the device quality and manufacturing history records have been checked for all available lot number and found to be according to specification valid during 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 the root cause of the failure is not product related. We assume that the failure is probably usage/patient related. Rationale: there are no hints for a material problem. According to the quality standard and dhr files a material defect and production error is improbable. One reason for loosening the rotation axis locknut postoperatively could be: when the connection between the axis taper and the femur could not firmly fitted, there is a gap and hence movement between the components. This leads to the femur safety nut unscrewing or to the axis breaking above the taper. The taper must be firmly pressed together and the femur safety nut assembled and pre-tightened using the instrument np420r. Then the counter-holder np419r together with the instrument np420r is used to tighten the taper with 20nm using the torque wrench n184m. The femur safety nut is then screwed on using holder np455r by hand. The counter-holder is then attached to the femur and the femur safety nut is then tightened with 20nm using the torque wench. When these steps are carried out accurately it should not be possible for the construct to come apart in situ. The visual examination shows typical damage to both the taper and the thread. The damage of the taper is an indication that the hinge connection of the femur has been moving on the taper. The position of the thread damage at the distal end of the femur safety nut indicates that the nut was not fully engaged on the thread of the axis. A further point to mention is the patient's height and weight, which also might contribute to the loose joining of the prosthetic components. No capa necessary.
Event Description
It was reported the locking nut loosened post-operatively. The patient was now presented with high instability (no event, no fall). An x-ray was performed and the patient was scheduled for revision surgery. During the revision surgery, it was found that the lock nut (nr860) had come loose. It was also found that the joining of the meniscal component nr880 had also come loose. A new nr881 insert with nr860 was implanted without any problems. Concomitant: nr880, enduro meniscal component f2 10mm 51737924; nr792k, enduro replacem. Tibia ring f/nr872/nr880 51776289; nb012k, enduro tibial comp. Offset cemented t2 unknown; nr291k, femur extens. Stem 6° d12x77mm cemented unknown; nr192k, tibia offset stem d15x52mm cemented unknown; nr377k, enduro femur spacer post/dist f2 4x8mm unknown; nb056k, enduro tibia hemi-wedge t2 8mm rl/lm unknown; nr400k, nut f/femur extens. Stem all sizes neutr. Unknown.
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Manufacturer (Section D)
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
kerstin rothweiler
am aesculap-platz
tuttlingen, baden-wurttemberg 78501
GM   78501
MDR Report Key8780064
MDR Text Key150682363
Report Number9610612-2019-00452
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2016
Device Model NumberNB015K
Device Catalogue NumberNB015K
Device Lot Number51756771
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/11/2019 Patient Sequence Number: 1