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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. 3DKNEE INSERT, 3D EX SZ 5RT 9MM

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ENCORE MEDICAL, L.P. 3DKNEE INSERT, 3D EX SZ 5RT 9MM Back to Search Results
Model Number 392-09-705
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 05/08/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was pain. The previous surgery and the revision detailed in this investigation occurred over 2 years and 9 months apart. 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 implant device history records (dhr) shows that the reported component used in the previous surgery met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to the pain. There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's pain. There are multiple factors that may contribute to the event that are outside the control of (b)(4) are soft tissue impingement, degenerative bone, excessive weight, unbalanced joint or trauma. No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery due to pain.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 5RT 9MM
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
MDR Report Key6619026
MDR Text Key118942344
Report Number1644408-2017-00423
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912120258
UDI-Public(01)00888912120258
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091956
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 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model Number392-09-705
Device Catalogue Number392-09-705
Device Lot Number59603594
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2013
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: 06/07/2017 Patient Sequence Number: 1
Treatment
233-02-105, LOT 905A1076; 324-01-104, LOT 233B1144
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