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

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 12 MM HEIGHT PROSTHESIS, 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 MANUFACTURING B.V. PERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 12 MM HEIGHT PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Information (3190)
Event Date 12/20/2016
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.
 
Manufacturer Narrative
The following sections could not be completed with the limited information provided. Weight-ni. Concomitant medical products: item number 42502006202, persona cemented cr femoral, lot number 62844035. Item number 42532006402, persona stemmed 5-degree tibia, lot number 63235981.
 
Event Description
It was reported that following a total knee arthroplasty, the patient underwent a revision approximately nine months post implantation due to loosening.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERSONA ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) RIGHT 12 MM HEIGHT
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6263291
MDR Text Key160791167
Report Number0002648920-2017-00021
Device Sequence Number1
Product Code OIY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK121771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number42522200412
Device Lot Number63057892
Other Device ID NumberN/A
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 Received09/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
-
-