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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENDURO MENISCAL COMPONENT F3 12MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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AESCULAP AG ENDURO MENISCAL COMPONENT F3 12MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number NR891M
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported to aesculap ag that an enduro meniscal component f3 12mm (part # nr891m) was used during a procedure performed on an unknown date. According to the complainant, the enduro uncoupled with locking nut and was lying freely in the joint. The patient underwent a revision procedure on an unknown date. The complaint device was returned to the manufacturer for evaluation. No patient complications were reported as a result of the revision surgery. Although requested, additional information has not been made available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameENDURO MENISCAL COMPONENT F3 12MM
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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 Key12711948
MDR Text Key278811052
Report Number9610612-2021-00676
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberNR891M
Device Catalogue NumberNR891M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2014
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: 10/28/2021 Patient Sequence Number: 1
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