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

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

  • 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
 

ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Catalog Number 114800
Device Problem Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2018
Event Type  Injury  
Event Description
Revision surgery - due to the ulna bearing being worn and not functioning correctly. The original surgery was done in 2006. The surgeon replaced the ulna bearing and condyle components.
 
Manufacturer Narrative
The reason for this revision surgery was due to worn components. The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. The healthcare professional indicated there was no delay in surgery and another suitable device was available for use. The revision surgery was completed as intended. The device was disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhr) was not conducted since the item and or lot number(s) was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. As of 21-may-2018, the records needed have not been forwarded by zimmer-biomet. Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated. The root cause of this complaint was a revision surgery due to worn components. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA BEARING KIT
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7683326
MDR Text Key113864137
Report Number1644408-2018-00639
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114800
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
Treatment
114700
-
-