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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC HUM 5X100MM RT FLANGED C

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ENCORE MEDICAL, L.P. DISCOVERY ELBOW DISC HUM 5X100MM RT FLANGED C Back to Search Results
Catalog Number 114907
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 04/24/2016
Event Type  Injury  
Event Description
Revision surgery - due to the ulna coming loose; it was removed and replaced with a longer length.
 
Manufacturer Narrative
Corrected the lot number from 287160 to 287150. Manufacturer narrative: the reason for this revision surgery was the ulna became loose. The implant was in vivo for 1. 1 months. 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. 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 (dhrs) revealed no discrepancies or issues with the manufacturing history of this part. All parts were found to meet design and manufacturing specifications. No non-conforming material reports (ncmr's) were associated with this part. The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review. This event is deemed to be non-product related. The root cause for the looseness was not reported. The surgeon reported no issues associated with the explanted product. The scope of this investigation is limited without having the parts available to djo surgical for evaluation. Other conditions, root cause, relating to this event could not be determined with confidence. 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 HUM 5X100MM RT FLANGED 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
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-5445
5128346255
MDR Report Key5674010
MDR Text Key45751004
Report Number1644408-2016-00300
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 04/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114907
Device Lot Number287150
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 Received06/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/09/2015
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: 05/23/2016 Patient Sequence Number: 1
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