• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 11MM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 8RT 11MM Back to Search Results
Model Number 392-11-708
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 03/14/2022
Event Type  Injury  
Event Description
Revision surgery: due to an infection.
 
Manufacturer Narrative
The reason for this revision surgery was reported as an infection. The previous surgery and the surgery detailed in this event occurred 3 years and 10 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 devices were disposed of at 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 possible 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. Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 8RT 11MM
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
james mcmahon
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key13955928
MDR Text Key288271130
Report Number1644408-2022-00396
Device Sequence Number1
Product Code OIY
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 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2018
Device Model Number392-11-708
Device Catalogue Number392-11-708
Device Lot Number59604335
Was Device Available for Evaluation? No
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2014
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: 03/30/2022 Patient Sequence Number: 1
Treatment
130-03-735 LOT 156N1317; 233-02-108 LOT 914A1429; 333-02-108 LOT 278B1177
-
-