MAUDE Adverse Event Report: OSARTIS GMBH CARDINAL HEALTH ARTHROPLASTY BONE CEMENT

Model Number	CMT-40-1
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2016, ms.(b)(6) underwent total left knee replacement by implanting surgeon, dr.(b)(6) with cardinal health arthroplasty bone cement.On (b)(6) 2019, ms.(b)(6) to undergo undergo a revision surgery due to aseptic loosening of his artificial knee components.No x-rays are available.No further information have been provided.

• Brand Name: CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
• Common Device Name: CARDINAL HEALTH ARTHROPLASTY BONE CEMENT
• Manufacturer (Section D): OSARTIS GMBH; lagerstrasse 11-15; dieburg, 64807 ; GM 64807
• MDR Report Key: 10028062
• Report Number: 9615014-2020-00007
• Device Sequence Number: 2629149
• Product Code: LOD
• UDI-Device Identifier: 10885380066511
• UDI-Public: 10885380066511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 06/30/2017
• Device Model Number: CMT-40-1
• Device Catalogue Number: CMT-40-1
• Device Lot Number: 15FA52050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 05/06/2020
• 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: 60 YR
• Patient Weight: 70