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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 6X100MM RT FLANGED C Back to Search Results
Catalog Number 114909
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 05/01/2018
Event Type  Injury  
Event Description
Revision surgery - due to the patient having a loose humeral component. The surgeon also replaced the condyles.
 
Manufacturer Narrative
The reason for this revision surgery was due to a loose humeral component. The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established. 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. Initial or prolonged hospitalization was required. 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 device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation. Given the limited information, extensive search for an invoice of the previous surgery produced no results. As of 21-may-2018, the records needed have not been forwarded by zimmer-biomet. Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated. The root cause of this complaint was a revision surgery due to a loose humeral component. The surgeon performed this procedure to remedy the patient's condition. This complaint will be closed with the item and or lot number unknown pending receipt of additional information. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 6X100MM RT FLANGED C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7515648
MDR Text Key108301738
Report Number1644408-2018-00459
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 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114909
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/15/2018 Patient Sequence Number: 1
Treatment
114700; 114700
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