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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA 4X75MM LT W BRNG C

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA 4X75MM LT W BRNG C Back to Search Results
Catalog Number 114822
Device Problems Fracture (1260); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as fracture and loosening. The previous surgery date is unknown. 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 components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no nonconforming material reports (ncmr) associated with the products that may have contributed to the reported event. The devices was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery. 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 a fracture and loosening. There were no findings during this investigation that indicate that the reported device was defective. The surgeon performed this procedure to remedy the patient's condition. No further action is deemed necessary. No other information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - patient had a periphrastic fracture and loosening. One of the screws was missing from the condyle. The surgeon found the loose screw and removed as well.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 4X75MM LT W BRNG C
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd
austin texas 78758
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd
austin texas 78758
Manufacturer Contact
teffany hutto
9800 metric blvd
austin,tx 78758-5445 
MDR Report Key8940857
MDR Text Key156398768
Report Number1644408-2019-00789
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 Non-Healthcare Professional
Type of Report Initial
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2014
Device Catalogue Number114822
Device Lot Number834930
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2009
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: 08/28/2019 Patient Sequence Number: 1
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