Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OTTOBOCK SE&CO. KGAA MODULAR POLYCENTRIC EBS KNEE JOINT
  • 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
 

OTTOBOCK SE&CO. KGAA MODULAR POLYCENTRIC EBS KNEE JOINT Back to Search Results
Model Number 3R60=VC
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Knee joint was sent in for repair.According to the information provided by the customer the knees bushings have come out and knee has locked.The patient did not fall.
 
Manufacturer Narrative
The evaluation showed, that the bolts in the upper part (backward) disengaged.The bearing is worn out.No fall or injury occurred due to this failure, but it could have led to patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MODULAR POLYCENTRIC EBS KNEE JOINT
Type of Device
MODULAR POLYCENTRIC EBS KNEE JOINT
Manufacturer (Section D)
OTTOBOCK SE&CO. KGAA
max naeder str. 15
duderstadt, 37115
GM  37115
Manufacturer (Section G)
OTTOBOCK SE & CO. KGAA
max-naeder-str. 15
duderstadt, 37115
GM   37115
Manufacturer Contact
dominik schmidt
max-naeder-str. 15
doderstadt 37115
0495527848
MDR Report Key14313822
MDR Text Key291357891
Report Number9616494-2022-00005
Device Sequence Number1
Product Code ISY
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number3R60=VC
Device Catalogue Number3R60=VC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-