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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X150MM RT FLANGED C

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ENCORE MEDICAL L.P. DISCOVERY ELBOW DISC HUM 4X150MM RT FLANGED C Back to Search Results
Catalog Number 114915
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2018
Event Type  Injury  
Event Description
Revision surgery - the implant began to loosen.
 
Manufacturer Narrative
The reason for this revision surgery was device loosening. The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established. 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. This complaint evaluation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation. 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 showed no present trends or on-going issues that are in need of review. As of 21 jan 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 loose implant. There was no information submitted with the complaint that would indicate a material, design, or manufacturing issue with the explanted part. Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted. 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 4X150MM RT FLANGED C
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key8152600
MDR Text Key129978017
Report Number1644408-2018-01122
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number114915
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1
Treatment
114700; 114700
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