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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATIONS U-STAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH ONCOLOGY KNEE SYSTEM SEGMENT

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UNITED ORTHOPEDIC CORPORATIONS U-STAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH ONCOLOGY KNEE SYSTEM SEGMENT Back to Search Results
Model Number 2915-1025
Device Problem Break (1069)
Patient Problem Hip Fracture (2349)
Event Date 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
One ustar ii 25 mm segment was reported as broken and the device was returned for evaluation. The manufacturing data of this device was verified and met the design specification. The original design met design, testing and safety requirements and received 510(k) clearance. However, the fracture condition of the returned device was inconsistent with fatigue testing results which follow by norms. Based on one failure, it was determined to increase the design fracture of safety to a higher level on the 25 mm segment. The modified design had increased the factor of safety to account for possible conditions the parts might see that are outside the norms of standard testing protocols.
 
Event Description
Per the patient they felt they broke something while walking on a level surface. Upon x-ray evaluation it was determined the 25mm segment had fractured. Dr. (b)(6) performed a left revision surgery and ex-planted the 25mm segment.
 
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Brand NameU-STAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
Type of DeviceONCOLOGY KNEE SYSTEM SEGMENT
Manufacturer (Section D)
UNITED ORTHOPEDIC CORPORATIONS
hsinchu city,
TW
Manufacturer Contact
lois ho
no 57, park ave 2,
science park
hsinchu city, 30075
TW   30075
MDR Report Key13510462
MDR Text Key286595588
Report Number9681642-2022-00001
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2915-1025
Device Catalogue Number2915-1025
Device Lot Number16E546A11
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2020
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: 02/10/2022 Patient Sequence Number: 1
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