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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION USTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH ONCOLOGY KNEE SYSTEM SEGMENT

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UNITED ORTHOPEDIC CORPORATION USTAR 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 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Description of the problem : the awareness of this case was received from the usa branch on (b)(6) 2021. It was reported that a patient who had undergone a prior hip primary surgery, and to be revised on (b)(6) 2021 after a missed step fall on patients right side. The device (no. 2915-1025, lot no. 19e272h) was found to be broken after x-rays were taken, the implant was extracted and the patient was revised. Root cause analysis: according to the investigation of capa no. (b)(4), (b)(4) pieces have been produced with lot number 19e272h and (b)(4) pieces have been sold to usa and taiwan subsidiary. After reviewing the "material certificate", "production history records" and "inspection records", all devices of the lot 19e272h were qualified and verified to be in spec with the design and material files and expectancy. This event is considered to be isolated, no similar events have been reported or are known to have occurred for this lot and device. The analysis test is in progress to further investigate the possible causes. Corrected data: investigation into the cause of the adverse event is in progress.
 
Event Description
It was reported to united orthopedic that a patient who had undergone a prior hip primary surgery, had to be revised after presenting to the hospital after a missed step fall on patients right side. Radiographs indicated the segment on the left.
 
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Brand NameUSTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
Type of DeviceONCOLOGY KNEE SYSTEM SEGMENT
Manufacturer (Section D)
UNITED ORTHOPEDIC CORPORATION
no 57, park ave 2
hsinchu city, 30075
TW 30075
Manufacturer Contact
lois ho
no 57, park ave 2
hsinchu city, 30075
TW   30075
MDR Report Key12317205
MDR Text Key266363228
Report Number9681642-2021-00001
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 Recall
Type of Report Initial,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2021
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 Number19E272H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number3009760038-08252021-001

Patient Treatment Data
Date Received: 08/13/2021 Patient Sequence Number: 1
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