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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem Description
It was reported to united orthopedic that a patient who had undergone a prior hip primary surgery, had to to be revised after presenting to the hospital after a missed step fall on patients right side.Radiographs indicated the segment on the left.
Additional Manufacturer Narrative
Additional evaluation of the explanted device, devices in the same lot, devices of the same size and a different lot, as well as devices of a different size were evaluated via documentation review as well as biomechanical testing.This testing led to the conclusion that the lot involved with this report is in question and as noted above in section h7, is now subject to a voluntary recall initiated by uoc usa.

• Brand Name: USTAR II KNEE SYSTEM SEGMENT PART, RHS, 25 MM LENGTH
• Common Device Name: ONCOLOGY KNEE SYSTEM SEGMENT
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no 57, park ave 2; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 12317205
• Report Number: 9681642-2021-00001
• Device Sequence Number: 14566570
• Product Code: KRO
• UDI-Device Identifier: 04719872148197
• UDI-Public: 04719872148197
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K190100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2025
• 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
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3009760038-08252021-001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82