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U.S. Department of Health and Human Services

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

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA E+ BEARING KIT Back to Search Results
Model Number 540-01-001
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 05/04/2020
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported due to loosening. The actual length of in-vivo for the items listed are 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 kept 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 - austin for review. The revised items were not returned for examination and the item and or lot numbers were not provided. To adequately investigate this event, the part and or lot numbers are necessary. Customer complaint history of the reported devices 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. This complaint will be closed pending receipt of additional information.
 
Event Description
Revision surgery - due to loosening.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA E+ BEARING KIT
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 
MDR Report Key10108757
MDR Text Key194309234
Report Number1644408-2020-00415
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051975
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 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number540-01-001
Device Catalogue Number540-01-001
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 Received05/04/2020
Was Device Evaluated by Manufacturer? No
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: 06/02/2020 Patient Sequence Number: 1
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