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

MAUDE Adverse Event Report: ZIMMER, INC. PERSONA 4 IN 1 ANTERIOR REFERENCING CUT GUIDE SIZE; INSTRUMENT, KNEE

  • 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, INC. PERSONA 4 IN 1 ANTERIOR REFERENCING CUT GUIDE SIZE; INSTRUMENT, KNEE Back to Search Results
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 05/08/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during initial operating room setup, the nurse handling the femoral provisional had black residue on her gloves.There was noticed to be black debris on the inside of the left and right femoral provisional.There were five sets examined and all five sets had the same black debris.As a result of the event, the surgery was delayed 35 minutes.No additional patient consequences were reported.
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Additional: updated corrected conclusion code.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint samples were evaluated and the reported event was confirmed.Examination of the returned parts found scratches on many of the tray components, suggesting repeated use.Sem / eds analysis of the debris found on the cut guides was performed and observed that the various effected areas were filled with debris which predominantly showed oxides.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause is attributed to a maintenance issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERSONA 4 IN 1 ANTERIOR REFERENCING CUT GUIDE SIZE
Type of Device
INSTRUMENT, KNEE
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6775776
MDR Text Key82109228
Report Number0001822565-2017-05269
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PK113369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Model NumberN/A
Device Catalogue Number42509908556
Device Lot Number63387267
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2017
Initial Date FDA Received08/08/2017
Supplement Dates Manufacturer Received08/28/2017
02/08/2018
03/21/2018
Supplement Dates FDA Received09/20/2017
02/09/2018
04/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
-
-