MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 5° D20X117 CEM.LESS; KNEE ENDOPROSTHESES

Model Number NR410Z

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

If additional information is received a follow up report will be submitted.Associated medwatches: 9610612-2019-00207; 9610612-2019-00208; 9610612-2019-00209; 9610612-2019-00210; 9610612-2019-00211; 9610612-2019-00212; 9610612-2019-00213.

Event Description

It was reported a 4 year 5 month post-op knee dislocated.A patient was sent to the emergency room (er) per surgeon recommendation, due to a dislocated columbus knee implant.The patient had initial surgery on (b)(6) 2014.The patient reported to the emergency room team that while getting out of a chair the knee locked up.An x-ray was taken to confirm the dislocation and the patient was scheduled for revision surgery with a tentative date of (b)(6) 2019, and it will likely be a poly exchange to a thicker more constrained poly.The patient's revision took place on (b)(6) 2019 with only the poly insert being revised.No other information has been provided.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Associated medwatches: 9610612-2019-00207, 9610612-2019-00208, 9610612-2019-00209, 9610612-2019-00210, 9610612-2019-00211, 9610612-2019-00212, 9610612-2019-00213.Manufacturing site evaluation: there are no devices available for investigation.Some x-ray figures were provided to us.Investigation: no product at hand, therefore an investigation is not possible.The provided x-rays give no hints for the root cause of the mentioned luxation.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 specifications 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 definitive root cause for the failure.It appears that the failure is not product related.It could be possible that the failure is patient related.Rationale: in the light of the small amount of information received and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a definitive root cause for the mentioned failure.There are no hints for a material problem.According to the quality standard and device history records (dhr) files a material defect and production error is improbable.Statement from product management representative: as this is a "post-jump", this refers to a flexion gap which is larger than the jumping distance of the implant.The performed jumping distance of the implant was exceeded by a large bend or stretch gap.Whether this excessive flexion already existed intraoperatively or was acquired postoperatively (for example, through trauma) can no longer be identified unequivocally.

• Brand Name: AS FEMUR EXTENS.STEM 5° D20X117 CEM.LESS
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8485242
• MDR Text Key: 141011679
• Report Number: 9610612-2019-00214
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: NR410Z
• Device Catalogue Number: NR410Z
• Device Lot Number: 51902722
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2019
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention