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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIGHLY CROSSED LINK KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS

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ENCORE MEDICAL L.P. HIGHLY CROSSED LINK KNEE DOMED TRI-PEG PATELLA, 32X8MM, E-PLUS Back to Search Results
Model Number 130-03-732
Device Problem Device Slipped (1584)
Patient Problem No Information (3190)
Event Date 05/30/2018
Event Type  Injury  
Event Description
Revision surgery - due to loosening of the patella.
 
Manufacturer Narrative
The reason for this revision surgery was due to the loosening of the patella. The previous surgery and the revision detailed in this investigation occurred 11 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 the loosening of the patella. 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.
 
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Brand NameHIGHLY CROSSED LINK KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 32X8MM, E-PLUS
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd
austin TX 78758 5445
MDR Report Key7570113
MDR Text Key110106056
Report Number1644408-2018-00560
Device Sequence Number1
Product Code OIY
UDI-Device Identifier00888912108539
UDI-Public(01)00888912108539
Combination Product (y/n)N
PMA/PMN Number
K113756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/02/2022
Device Model Number130-03-732
Device Catalogue Number130-03-732
Device Lot Number155N1272
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/05/2018 Patient Sequence Number: 1
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