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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC ULNA BEARING KIT Back to Search Results
Catalog Number 114800
Device Problem Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to a worn poly. The actual length of in-vivo for the item listed 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 records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation. Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review. Given the limited information, a search for an invoice of the previous surgery produced no results. As of 5-mar-2019, the records needed have not been forwarded by zimmer-biomet. Should zimmer-biomet provide the needed records at a later time, this investigation shall be updated. The root cause of this complaint was a revision surgery due to worn poly. The surgeon performed this procedure to remedy the patient's condition. 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 - due to the poly bearing having worn and needing to be replaced.
 
Manufacturer Narrative
Corrected data: upon further quality assurance evaluation, part number 114800 was incorrectly reported on the initial report. The main component is an unknown discovery.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA BEARING KIT
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 Key8425698
MDR Text Key138963610
Report Number1644408-2019-00209
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 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2019
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: 03/15/2019 Patient Sequence Number: 1
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