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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X155MM RT W BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA 3X155MM RT W BRNG C Back to Search Results
Catalog Number 114819
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 07/29/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as loosening. The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established. 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 devices were disposed of at hospital and not made available to djo surgical for examination. This investigation is limited in scope as only partial information was provided to djo surgical. The revised items were not returned for examination and the lot numbers were not provided. To adequately investigate this event, the lot numbers are necessary. If this information is submitted at a future date, this investigation will be re-evaluated. Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to loosening. There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event. The surgeon performed this revision to remedy the patient's condition. This complaint will be closed pending receipt of additional information.
 
Event Description
Revision surgery - ulna stem loosening.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 3X155MM RT W BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx 78758-5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key10553711
MDR Text Key207555805
Report Number1644408-2020-00771
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 09/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114819
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
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

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
Treatment
540-00-000 LOT UNKNOWN
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