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

MAUDE Adverse Event Report: ZIMMER CAS SESAMOID PLASTY CAMERA KIT - P7 ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • 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
 

ZIMMER CAS SESAMOID PLASTY CAMERA KIT - P7 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Calibration Problem (2890)
Patient Problem No Code Available (3191)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: (b)(6). Customer has indicated that the product will be returned for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that discrepancies were found the actual and planned tibial resection during a knee arthroplasty, requiring additional cuts to be made. No additional patient consequence reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSESAMOID PLASTY CAMERA KIT - P7
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer (Section G)
ZIMMER CAS
75 queen str.
suite 3300
montreal, quebec H3C 2 N6
CA H3C 2N6
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8716113
MDR Text Key148550676
Report Number0009617840-2019-00002
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K110054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number521.036
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/20/2019 Patient Sequence Number: 1
-
-