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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C Back to Search Results
Catalog Number 114905
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 04/26/2018
Event Type  Injury  
Event Description
Revision surgery - due to the humeral component being loose. The surgeon replaced it with a longer one.
 
Manufacturer Narrative
The reason for this revision surgery was due to a loose humeral component. The previous surgery and the revision detailed in this investigation occurred 1. 2 years 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. As of 22-may-2018, no device history records (dhr) have been forwarded by zimmer-biomet concerning the items listed in this complaint, therefore a device history records (dhr) review could not be performed. Should zimmer-biomet provide the records needed for review, the complaint will be re-opened and a further review shall be conducted. 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 humeral component. 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.
 
Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X100MM RT FLANGED C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7512477
MDR Text Key108223679
Report Number1644408-2018-00439
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,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114905
Device Lot Number473370
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/14/2018 Patient Sequence Number: 1
Treatment
114700, LOT 611270; 402439, LOT 247480
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