• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHESES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG COLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE KNEE ENDOPROSTHESES Back to Search Results
Model Number AE-QAS-K521-55
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Implant Pain (4561)
Event Date 05/03/2021
Event Type  Injury  
Event Description
It was reported that there was an issue with aesculap010 - aesculap surgical instruments. According to the complaint description, the as enduro knee (right knee) was revised due to pain, swelling and loosening. The as endoro was allegedly implanted on (b)(6) 2019 and revised on (b)(6) 2021. A revision surgery was necessary. Additional information was not provided. Additional patient information is not available. (b)(4).
 
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOLLECT.NO.QAS KNEE IMPLANTS ROTAT.HINGE
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 Key12910838
MDR Text Key286004034
Report Number9610612-2021-00750
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/25/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAE-QAS-K521-55
Device Catalogue NumberAE-QAS-K521-55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2022
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: 12/01/2021 Patient Sequence Number: 1
-
-