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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIGHLY CROSS LINKED KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS

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ENCORE MEDICAL L.P. HIGHLY CROSS LINKED KNEE DOMED TRI-PEG PATELLA, 35X9MM, E-PLUS Back to Search Results
Model Number 130-03-735
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Information (3190)
Event Date 10/30/2017
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was due to loosening. The previous surgery and the revision detailed in this investigation occurred 1 year and 3 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 loosening. 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 many factors that may contribute to the event that are outside the control of djo surgical such as: loose joints from inadequate soft tissue support, degenerative bone, patient bone deterioration, weak thigh muscles, patient activities or trauma. 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 the patella being loose. The surgeon removed it and the bone was prepped again. A new patella was cemented in.
 
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Brand NameHIGHLY CROSS LINKED KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 35X9MM, E-PLUS
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
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key7029427
MDR Text Key149222777
Report Number1644408-2017-01031
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912108553
UDI-Public(01)00888912108553
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/17/2021
Device Model Number130-03-735
Device Catalogue Number130-03-735
Device Lot Number156N1110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/23/2016
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: 11/14/2017 Patient Sequence Number: 1
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