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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 10LT 9MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 10LT 9MM Back to Search Results
Model Number 391-09-710
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 05/26/2020
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 2. 6 months apart. Initial or prolonged hospitalization was 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 device was disposed of at hospital and not made available to djo surgical for examination. A review of the device history record (dhr) show that the reported component 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 product that may have contributed to the reported event. The device was verified to have gone through an acceptable sterilization process and was 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 device was 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 - due to an infection.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 10LT 9MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx
Manufacturer (Section G)
ENCORE MEDICAL L.P.
9800 metric blvd
austin, tx
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, tx 
MDR Report Key10184952
MDR Text Key196129524
Report Number1644408-2020-00479
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912118996
UDI-Public(01)00888912118996
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number391-09-710
Device Catalogue Number391-09-710
Device Lot Number286G1965
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2019
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: 06/23/2020 Patient Sequence Number: 1
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