• 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 METHA SHORT HIP STEM CAP SIZE 2 HIP 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 METHA SHORT HIP STEM CAP SIZE 2 HIP ENDOPROSTHETICS Back to Search Results
Model Number NC082T
Device Problem Compatibility Problem (2960)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/27/2019
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 metha hip stem. On (b)(6) 2009 the patient was advised to receive a surgery to treat the left hip coxarthrosis. On (b)(6) 2010 the same was advised for the right hip. Following both surgeries the patient suffered from unspecified "severe and permanent consequences", due to metallosis caused by the defective prosthesis. The patient was treated by a physician and revision(s) were performed. A revision surgery was necessary. Information about the involved products has been received, related to b)(4). The adverse event/malfunction is filed under (b)(4). Associated medwatch-reports: 9610612-2020-00080 - this report. 9610612-2020-00081 ((b)(4) nc088k). 9610612-2020-00082 ((b)(4) nc082t). Same patient- involved component (b)(4) nc088k-51555649. (9610612-2019-00781).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMETHA SHORT HIP STEM CAP SIZE 2
Type of DeviceHIP 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
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key9849315
MDR Text Key184318987
Report Number9610612-2020-00080
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K071916
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,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2016
Device Model NumberNC082T
Device Catalogue NumberNC082T
Device Lot Number51540632
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2009
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: 03/18/2020 Patient Sequence Number: 1
-
-