• 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. UNKNOWN ULNAR STEM ELBOW, PROSTHESIS

  • 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. UNKNOWN ULNAR STEM ELBOW, PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 11/03/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) report source, foreign - the event occurred in (b)(6). Report source, literature - ernstbrunner, l. Et al (2018). Long-term results of total elbow arthroplasty in patients with hemophilia. Journal of shoulder and elbow surgery, 27(1), 126-132. Doi: 10. 1016/j. Jse. 2017. 09. 009 reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined. 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. Product location unknown.
 
Event Description
It was reported in a journal article that at (b)(6) a patient had advanced bushing wear three years post op revision with good subjective and objective clinical outcome. No further information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN ULNAR STEM
Type of DeviceELBOW, PROSTHESIS
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 Key7321597
MDR Text Key101795709
Report Number0001822565-2018-01368
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model 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 Received03/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/07/2018 Patient Sequence Number: 1
-
-