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	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, (b)(6) underwent left-sided total knee replacement surgery performed by dr.(b)(6) at (b)(6) hospital in (b)(6).He was implanted with biomet vanguard components.On (b)(6) 2018, in order to bond these components, dr.(b)(6) utilized the defective cardinal hv bone cement.After the cardinal hv bone cement was implanted, mr.(b)(6) began experiencing severe and persistent pain, discomfort, instability and difficulty ambulating due to aseptic loosening.On (b)(6) 2019, patient underwent revision surgery due to gross loosening of his knee components in his left knee.This surgery was performed by dr.(b)(6) at (b)(6) hospital in (b)(6).In this procedure, dr.(b)(6) assessed the implant components and found "gross loosening of the tibial component." 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; auf der beune 101; muenster, 64839 ; GM 64839
• MDR Report Key: 10527111
• Report Number: 9615014-2020-00011
• Device Sequence Number: 3221918
• 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: 2018
• 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): 09/14/2020

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: 02/28/2019
• Device Model Number: CMT-40-1
• Device Catalogue Number: CMT-40-1
• Device Lot Number: 17BA52080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET VANGARD KNEE SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 70