MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION OFFSET STEM ADAPTER, OFFSET 4MM; SEMI-CONSTRAINED TOTAL KNEE PROSTHESES

Catalog Number	2903-3020
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to uoc that a patient who had undergone a prior knee revision surgery, had to be revised.In the revision, the surgeon removed a broken device and implanted new revision components.

• Brand Name: OFFSET STEM ADAPTER, OFFSET 4MM
• Common Device Name: SEMI-CONSTRAINED TOTAL KNEE PROSTHESES
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; 57 park avenue 2, science park; hsinchu, east district 30075 ; TW 30075
• MDR Report Key: 7542745
• Report Number: 3009760038-2018-70002
• Device Sequence Number: 1696895
• Product Code: JWH
• UDI-Device Identifier: 04712771509908
• UDI-Public: 04712771509908
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018
• Report Date (Section F): 05/24/2018

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 Expiration Date: 08/06/2020
• Device Catalogue Number: 2903-3020
• Device Lot Number: 15H008A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2018
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Date Report Sent to FDA: 05/24/2018