MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T2 16MM RM/LL; KNEE ENDOPROSTHESES

Model Number NB048Z

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

(b)(4) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: (b)(4).(b)(4).Manufacturing site evaluation: devices are not available because the components are still implanted.No pictures were provided; surgical specimen and final results provided.We do not know the consistency and origin of the mentioned tissue with blackened appearance.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.Conclusion and root cause - based on the information available, it is not possible to determine a possible root cause for the failure.At this time we assume that the failure is not product related.It could be possible that the failure is usage/patient related.Rationale - in light of the incomplete information received about the lab results, and due to the circumstance that we did not receive the complained devices for investigation, it is not possible to determine a root cause for the mentioned failure.There are no hints for a material problem.According to the quality standard and files a material defect and production error is improbable.At this time we exclude a design-related error because the market feedback is unremarkable on this matter.A maintenance failure also can be excluded because this issue is only relevant for instruments.It could be possible that due to so-called "third-body wear" (such wear includes foreign particles for example bone cement, bone, or metal particles) in the knee mechanism (bush bearing) lead to a peek abrasion which could lead potentially to the mentioned blackened tissue.A capa is not necessary.

Event Description

It was reported that a patient was initially implanted with enduro knee products in the right knee on (b)(6) 2018.Later, the patient presented with joint pain and stiffness; after examination, it was determined that a "wash-out" was necessary.On (b)(6) 2019, the patient underwent an arthrotomy of the knee and synovectomy; antibiotic beads were inserted for treatment of septic right knee.Tissue specimens were taken; tissues had a blackened appearance.The intercondular box had the highest concentration of blackened tissue, also tissue in the patellar tendon.No damage to any of the components was observed, neither was there indications of loosening of the hinge mechanism.A thorough washout was performed and the wound closed.Results showed acute inflammation/neutrophilic infiltration, and granulation tissue formation; no definitive evidence of malignancy.No additional patient harm or intervention has been reported since the surgery.Associated components (also reported separately): as femur stem neutral, as enduro femur spacer, as nut for femur stem, as enduro femoral component, as enduro femur spacer, patella, as tibia offset stem as enduro meniscal component, as enduro tibial hemi-wedge x 4, as enduro tibial component.

• Brand Name: AS ENDURO TIBIA HEMI-WEDGE T2 16MM RM/LL
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, PA 18034
• MDR Report Key: 8671843
• MDR Text Key: 147095834
• Report Number: 9610612-2019-00337
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB048Z
• Device Catalogue Number: NB048Z
• Device Lot Number: 52041417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/29/2019
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention