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

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.

• Brand Name: USTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
• Type of Device: ONCOLOGY 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 Key: 12317205
• MDR Text Key: 266363228
• Report Number: 9681642-2021-00001
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190100
• Number of Events Reported: 1
• 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 Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2915-1025
• Device Catalogue Number: 2915-1025
• Device Lot Number: 19E272H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3009760038-08252021-001

Patient Treatment Data

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