• 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 AS FEMUR EXTENS.STEM 6° D18X77 CEMENTED KNEE ENDOPROSTHETICS

  • 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 AS FEMUR EXTENS.STEM 6° D18X77 CEMENTED KNEE ENDOPROSTHETICS Back to Search Results
Model Number NR293Z
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Swelling (2091)
Event Date 03/05/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). No product at hand, therefore a failure description is not possible. Due to the circumstance that it is unknown which of the mentioned components could be responsible for the mentioned suspicion of metallosis all components were created as leading material. This case was discussed with a specialist from the product management. Without the explanted devices it is not possible to determine the root cause for the mentioned suspicion of metallosis. There are no information how significant the metal debris (metallosis) in the patient exist. Furthermore a metallosis within 16 days postoperative is very unusual. 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 specification 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 possible root cause for the failure. At that time we assume that the failure is not product related. Rationale: due to the circumstances that we did not receive any devices for investigation it is not possible to determine a conclusion and root cause. There are no hints for a material problem. According to the quality standard and dhr files a material defect and production error can be excluded.
 
Event Description
It was reported suspicion of metallosis 16 days post-operatively. Per the reporter: metallosis prosthetic joint in absence of microscopic ruptures in the prosthetic implant with the limits related to the intraoperatory valuation. Clarification has been requested on the above statement. It was also reported per the doctors, the patient started with localized pain and swelling of the knee. It is unknown if blood test for the metallosis diagnosis are available. An enduro prosthesis was used as a revision of a precedent prosthesis (date and manufacturer of precedent prosthesis is unknown). After having removed the enduro prosthesis, a cement spacer was inserted. Per the reporter, the patient will probably be admitted for a new prosthesis intervention when the blood values are within normal range. The patient also has a prosthesis in the other knee (unknown type or when this was implanted). Additional information has been requested, however, not yet received. All med watch submissions related to this are: 9610612-2019-00238, 9610612-2019-00226, 9610612-2019-00227, 9610612-2019-00228 (this report), 9610612-2019-00229, 9610612-2019-00230, 9610612-2019-00231, 9610612-2019-00232, 9610612-2019-00233, 9610612-2019-00234, 9610612-2019-00235.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAS FEMUR EXTENS.STEM 6° D18X77 CEMENTED
Type of DeviceKNEE ENDOPROSTHETICS
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key8501792
MDR Text Key141573395
Report Number9610612-2019-00228
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNR293Z
Device Catalogue NumberNR293Z
Device Lot Number52279596
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/28/2019
Device Age27 MO
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2016
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: 04/10/2019 Patient Sequence Number: 1
-
-