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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE, PATELLA IMP DOME 40 X 10MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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ARTHREX, INC. IBALANCE, PATELLA IMP DOME 40 X 10MM; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number IBALANCE, PATELLA IMP DOME 40 X 10MM
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/04/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that a patient had an adverse reaction several years after implantation.Additional information requested.
 
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Brand Name
IBALANCE, PATELLA IMP DOME 40 X 10MM
Common Device Name
PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key12364345
Report Number1220246-2021-03560
Device Sequence Number4068045
Product Code KRR
UDI-Device Identifier00888867106840
UDI-Public00888867106840
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K143047
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberIBALANCE, PATELLA IMP DOME 40 X 10MM
Device Catalogue NumberAR-504-PSE0
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/04/2021
Initial Report FDA Received Date08/25/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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