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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 RT W/BRNG C

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC ULNA 4X75MM RT W/BRNG C Back to Search Results
Catalog Number 114823
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 12/01/2016
Event Type  Injury  
Event Description
Revision surgery - due to the surgeon implanted a total elbow in the patient roughly 10 years ago and the ulnar component loosened.
 
Manufacturer Narrative
The reason for this revision surgery was the ulnar component loosened. The actual length of in-vivo patient service was 8 years. 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 a lot number was not provided or determined during the complaint evaluation. A search of the device investigation history produced no anomalies or evidence of a product issue. Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event. Zimmer-biomet was contacted for additional information through an invoice search and they provided an original surgery date but no other information that advanced the complaint evaluation. This complaint will be closed with the lot unknown pending receipt of additional information. Should additional information become available concerning this complaint, the complaint will be re-opened and a further review shall be conducted. This event is deemed to be non-product related. The root cause for the ulnar component loosening was not reported. The scope of this investigation is limited without having the parts available to djo surgical for evaluation. Other conditions relating to this event could not be determined with confidence. The surgeon reported no issues associated with the explanted product. Inventory containment is not required as 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 ULNA 4X75MM RT W/BRNG C
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd.
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key6201536
MDR Text Key63184693
Report Number1644408-2016-01021
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
Type of Report Initial,Followup
Report Date 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/22/2016 Patient Sequence Number: 1
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