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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. MOVATION KNEE DOMED TRI-PEG PATELLA, 38X9MM, E-PLUS

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ENCORE MEDICAL L.P. MOVATION KNEE DOMED TRI-PEG PATELLA, 38X9MM, E-PLUS Back to Search Results
Model Number 130-03-738
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Joint Laxity (4526)
Event Date 03/08/2022
Event Type  Injury  
Manufacturer Narrative
The reason for this revision surgery was reported as pain and loosening. The previous surgery and the surgery detailed in this event occurred 11 months and 2 weeks apart. 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 devices were disposed of at hospital and not made available to djo surgical for examination. 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 products 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 pain and loosening. There were no findings during this evaluation that indicate the reported devices were 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. There are multiple factors that may 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 - loose knee and pain, patella was loose. No known trauma.
 
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Brand NameMOVATION KNEE
Type of DeviceDOMED TRI-PEG PATELLA, 38X9MM, 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
kiersten soderman
9800 metric blvd
austin, TX 78758-5445
MDR Report Key13876460
MDR Text Key287787685
Report Number1644408-2022-00359
Device Sequence Number1
Product Code OIY
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 Non-Healthcare Professional
Type of Report Initial
Report Date 03/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number130-03-738
Device Catalogue Number130-03-738
Device Lot Number157N1300
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2019
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: 03/24/2022 Patient Sequence Number: 1
Treatment
343-10-709 LOT 013U1054
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