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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 3RT 11MM

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ENCORE MEDICAL L.P. 3D KNEE INSERT, 3D EX SZ 3RT 11MM Back to Search Results
Model Number 392-11-703
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of Range of Motion (2032); No Code Available (3191)
Event Date 12/10/2018
Event Type  Injury  
Event Description
Revision surgery - due to the patient's knee being tight in flexing and extension. The surgeon removed and replaced the insert.
 
Manufacturer Narrative
The reason for this revision surgery was due to tightening of knee at flexion and extension (lack of range of motion). The previous surgery and the revision detailed in this investigation occurred 5. 1 months apart. There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery. There are no reported pre-existing patient health conditions. 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 (dhr) shows 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 the event. The device was within its expiration date at the time of use during the previous surgery. Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review. The root cause of this complaint was a revision surgery due to tightening of knee at flexion and extension (lack of range of motion). There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the event. There are multiple factors that may contribute to the event that are outside the control of djo surgical such as: patient activities, pre-operative restricted motion, ligament tear, joint swelling, insufficient physical therapy post-surgery or trauma. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 3RT 11MM
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key8187154
MDR Text Key131125596
Report Number1644408-2018-01172
Device Sequence Number1
Product Code OIY
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 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/03/2022
Device Model Number392-11-703
Device Catalogue Number392-11-703
Device Lot Number334G1046
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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