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

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14MM 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 BIOMET, INC. ZIMMER SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Staphylococcus Aureus (2058)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products ¿ zimmer segmental polyethylene insert xt size c catalog #: 00585001396 lot #: 63914744, zimmer segmental distal xt femoral component size c catalog #: 00585004301 lot #: 63970726, zimmer segmental precoat tibial component size 4 catalog #: 00588000400 lot #: 63914801, zimmer segmental precoat tibial augment block size 4 10mm catalog #: 00588000410 lot #: 62013221, zimmer segmental precoat stem extension catalog #: 00585205013 lot #: 63786590, zimmer segmental stem collar catalog #: 00585204035 lot #: 64080211. The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital does not typically release implants and the sales representative was concerned about handling the infected prostheses. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2019-00897.
 
Event Description
It is reported that the patient underwent a left knee arthroplasty revision of the polyethylene components to address a (b)(6) that developed within approximately seven (7) weeks post-operatively. No additional patient consequences were reported.
 
Manufacturer Narrative
The product was evaluated through manufacturing review, however, the reported event was unable to be confirmed. The device history records were reviewed and no discrepancies were identified. Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. Therefore, it is highly unlikely that the specified device caused any patient infection. Per package insert for the zimmer segmental system, infection is a known adverse effect of this procedure. However, a definitive root cause could not be determined with the information provided. 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.
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIMMER SEGMENTAL ARTICULAR SURFACE WITH SEGMENTAL HINGE POST SIZE C 14MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8369665
MDR Text Key137120292
Report Number0001822565-2019-00896
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K070978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00585003014
Device Lot Number63644221
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/26/2019 Patient Sequence Number: 1
-
-