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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS

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ENCORE MEDICAL L.P. 3D KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS Back to Search Results
Model Number 130-03-732
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 09/23/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The previous surgery and the surgery detailed in this event occurred 1. 5 years apart. Initial or prolonged hospitalization is required. 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 devices were disposed of at the hospital and not made available to djo surgical for examination. A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event. The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery. Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review. The root cause of this complaint was a revision surgery due to an infection. There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection. 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. There are multiple factors that may contribute to an infection that are outside the control of djo surgical. There are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - patient acquired an post-operative infection. Surgeon performed a resection and placed a antibiotic articulating spacer.
 
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Brand Name3D KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 32X8MM, E-PLUS
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 Key9208398
MDR Text Key162992339
Report Number1644408-2019-00991
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912108539
UDI-Public(01)00888912108539
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/01/2021
Device Model Number130-03-732
Device Catalogue Number130-03-732
Device Lot Number155N1107
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2016
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: 10/18/2019 Patient Sequence Number: 1
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