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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 5LT 13MM

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ENCORE MEDICAL L.P. 3DKNEE INSERT, 3D EX SZ 5LT 13MM Back to Search Results
Model Number 391-13-705
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 12/21/2018
Event Type  Injury  
Event Description
Revision surgery - due to the patient having an infection.
 
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The previous surgery and the revision detailed in this investigation occurred 5 years apart. No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system. 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 implant device history records (dhrs) show 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 an infection. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery. There were no findings during this investigation that indicate that the reported device was the root cause or had a direct connection with the patient's infection. There are multiple factors that may contribute to an infection that are outside of the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand Name3DKNEE
Type of DeviceINSERT, 3D EX SZ 5LT 13MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key8250683
MDR Text Key133147647
Report Number1644408-2019-00034
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912119498
UDI-Public(01)00888912119498
Combination Product (y/n)N
PMA/PMN Number
K091956
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2017
Device Model Number391-13-705
Device Catalogue Number391-13-705
Device Lot Number59602745
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/15/2019 Patient Sequence Number: 1
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