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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 4RT 13MM

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ENCORE MEDICAL, L.P. 3D KNEE INSERT, 3D EX SZ 4RT 13MM Back to Search Results
Model Number 392-13-704
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 03/19/2019
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to loosening. The previous surgery and the surgery detailed in this investigation occurred 12. 8 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, when released for use, met design and manufacturing requirements. There were no non-conforming material reports (ncmrs) 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 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 loosening. There were no findings during this investigation that indicate that the reported device was defective. There are multiple factors that may contribute to an event that are outside of the control of djo surgical. Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.
 
Event Description
Revision surgery - due to tibial and femoral loosening.
 
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Brand Name3D KNEE
Type of DeviceINSERT, 3D EX SZ 4RT 13MM
Manufacturer (Section D)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758 6313
Manufacturer (Section G)
ENCORE MEDICAL, L.P.
9800 metric blvd.
austin TX 78758 6313
Manufacturer Contact
teffany hutto
9800 metric blvd.
austin, TX 78758-6313
MDR Report Key8526928
MDR Text Key142341294
Report Number1644408-2019-00324
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912120753
UDI-Public(01)00888912120753
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 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/28/2019
Device Model Number392-13-704
Device Catalogue Number392-13-704
Device Lot Number59605051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2014
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: 04/18/2019 Patient Sequence Number: 1
Treatment
010-55-020, LOT 005A1232; 010-55-020, LOT 005A1233; 010-55-025, LOT 006A1346; 010-55-025, LOT 006A1349; 236-02-104, LOT 963A1057; 335-02-104, LOT 304B1041
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