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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC CONDYLE KIT WITH HEXALOBULA Back to Search Results
Catalog Number 114700
Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 03/14/2018
Event Type  Injury  
Event Description
Revision surgery - due to the poly becoming loose from ulna component and was very worn. The ulna component was placed in 2003.
 
Manufacturer Narrative
Corrected data: added concomitant part. Manufacturer narrative: the reason for this revision surgery was due to the poly becoming loose from ulna. The original surgery date was not provided or could be established therefore the length of in-vivo service can not be determined. 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. A review of the device history record (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation. No additional information was obtained to assist in the event identification. As of 6-apr-2018, no records have been forwarded by zimmer-biomet concerning this event. Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted. The root cause of this complaint was a revision surgery due the poly becoming loose from ulna. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. 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 CONDYLE KIT WITH HEXALOBULA
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7355560
MDR Text Key102992164
Report Number1644408-2018-00243
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K051975
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114700
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
Treatment
114800
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