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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 8RT 11MM

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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 Problems Fall (1848); Osteolysis (2377)
Event Date 11/15/2021
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as an instability after a fall and poly wear. The previous surgery and the surgery detailed in this event occurred 10 years apart. The health care 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 returned to manufacturer and the evaluation anticipated but not yet begun at djo surgical. 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 product 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 instability after a fall and poly wear. There were no findings during this evaluation that indicate the reported device was defective. No other 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 event. Agent has clearly mentioned that "patient fell" and there are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma. 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.
 
Event Description
Revision surgery - due to a fall patient tore posterior cruciate ligament, causing instability. A thicker poly was implanted 15mm and stability was achieved. In addition, osteolysis was occurring in the joint capsule due to existing poly wear.
 
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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
kiersten soderman
9800 metric blvd
austin, tx 78758-5445 
MDR Report Key12987002
MDR Text Key282185760
Report Number1644408-2021-01378
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 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2016
Device Model Number392-11-708
Device Catalogue Number392-11-708
Device Lot Number59601403
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/19/2011
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: 12/13/2021 Patient Sequence Number: 1
Treatment
335-02-108 LOT 53982535
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