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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X100MM RT FLANGED C Back to Search Results
Catalog Number 114905
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
Event Date 02/14/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was the surgeon believed the implant had reached maturity status and the patient needed a revision. 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 (b)(4) for examination. A review of the device history record (dhr) was not conducted since a lot was not provided or determined during the complaint evaluation. Multiple searches of the (b)(4) surgical records and patient database revealed no additional information concerning this event. Zimmer-biomet was contacted for additional information through an invoice search and reported they have no additional information to report for this 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. A search of the device investigation history produced no anomalies or evidence of a product issue. This complaint is deemed to be non-product related. The complaint states the surgeon believed the implant had reached maturity status and the patient needed a revision. 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 (b)(4) for evaluation. Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - reported as due to being really old.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC HUM 4X100MM RT FLANGED 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 Key6409696
MDR Text Key109407492
Report Number1644408-2017-00143
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 06/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114905
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 Received05/30/2017
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: 03/16/2017 Patient Sequence Number: 1
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