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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X75MM RT W BRNG C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW; DISC ULNA 3X75MM RT W BRNG C Back to Search Results
Catalog Number 114813
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Pain (1994)
Event Date 06/19/2017
Event Type  Injury  
Event Description
Revision surgery: due to the patient experiencing pain because the components became loose.
 
Manufacturer Narrative
The reason for this revision surgery was the patient was experiencing pain because components came loose.The actual length of in-vivo patient service for this product 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.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.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.This complaint will be closed with the lot number unknown pending receipt of additional information.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint is deemed to be non-product related.The complaint states the patient was experiencing pain because the components came loose.This revision was necessary to correct the patient's condition.No other conditions relating to this event could be determined with confidence.The surgeon reported no issues associated with the explanted product.The complaint investigation is limited in scope since the part (s) associated with this investigation was not returned to djo surgical for evaluation.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 Name
DISCOVERY ELBOW
Type of Device
DISC ULNA 3X75MM RT W BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd.
austin TX 78758 5445
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
MDR Report Key6726249
MDR Text Key80493060
Report Number1644408-2017-00607
Device Sequence Number1
Product Code JDC
UDI-Device Identifier00888912225151
UDI-Public(01)00888912225151
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 Other
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number114813
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/19/2017
Initial Date FDA Received07/19/2017
Supplement Dates Manufacturer Received08/07/2017
Supplement Dates FDA Received09/06/2017
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age73 YR
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