• 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. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES

  • 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. ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY PROSTHESIS, EXTREMITIES Back to Search Results
Model Number N/A
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Pain (1994)
Event Date 03/05/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown humeral component. Unknown articulation kit. Report source: (b)(6). The product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00891. Product not returned.
 
Event Description
It was reported patient underwent a revision procedure approximately 14 months post-implantation due to loosening and pain.   attempts have been made and additional information on the reported event is unavailable at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY
Type of DevicePROSTHESIS, EXTREMITIES
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9843505
MDR Text Key184461676
Report Number0001822565-2020-00892
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K123862
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 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840001407
Device Lot Number63710294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2018
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: 03/17/2020 Patient Sequence Number: 1
-
-