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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO MENISCAL COMPONENT F3 12MM KNEE ENDOPROSTHESES

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AESCULAP AG AS ENDURO MENISCAL COMPONENT F3 12MM KNEE ENDOPROSTHESES Back to Search Results
Model Number NR891Z
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with as enduro meniscal component. After opening up the incision, during a hinged knee revision, it appeared that the locking ring had come off, which caused the hinge to detach. The peek bushing was loose and disintegrated. The poly was also dislodged from the tibial baseplate. Upon examining the implant, the surgeon was able to keep the implant in place and replace the poly insert, bushing and locking ring. The extensor mechanism was recreated/replaced with allograft material. The surgeon cleaned up the black tissue and closed the patient. There was a comment noted that the blackened tissue was metallosis, but a tissue sample was not taken. Additional information was not provided nor available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameAS ENDURO MENISCAL COMPONENT F3 12MM
Type of DeviceKNEE 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
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10970723
MDR Text Key220407553
Report Number9610612-2020-00910
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
D138739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNR891Z
Device Catalogue NumberNR891Z
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/08/2020 Patient Sequence Number: 1
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