• 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 3X115MM LT W BRNG C

  • 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 3X115MM LT W BRNG C Back to Search Results
Catalog Number 114816
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2018
Event Type  Injury  
Event Description
Revision surgery - due to stem becoming loose.
 
Event Description
Second revision surgery - due to stem becoming loose.
 
Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was due to a loose stem. The previous surgery and the revision detailed in this investigation occurred 3. 4 months apart. 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 implant device history records (dhr), shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the reported event. As of 27-jun-2018, the records needed to verify an acceptable sterilization process, have not been forwarded by zimmer-biomet. Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to loose stem. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as 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 3X115MM LT W BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7561232
MDR Text Key109805082
Report Number1644408-2018-00554
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 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/25/2020
Device Catalogue Number114816
Device Lot Number626320
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
Treatment
114700, LOT 440710; 114700, LOT 533960; 114700, LOT 440710
-
-