MAUDE Adverse Event Report: MATORTHO MEDIAL ROTATION KNEE (MRK) KNEE SYSTEM; MEDIAL ROTATION KNEE LEFT TIBIA

Catalog Number	156-513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mrk implants were explanted on (b)(6) 2019.The device history record relating to the manufacture of part number 156-513 cannot be performed as the lot number of the explant was unable to be provided by the facility and the explant had been disposed of.If was confirmed that the revision procedure was completed successfully, however, a revision system from another company was used.
Event or Problem Description
"revision left knee (mrk), poly liners and resurfacing patella." "operation date: (b)(6) 2019.Patient has the following implants: femur size 2, tibia size 1, 13mm poly, 20mm patella.Patient was originally done by mr.(b)(6) at (b)(6) hospital on (b)(6) 2006." revision left knee (mrk), poly liners and resurfacing patella." (b)(4).

• Brand Name: MEDIAL ROTATION KNEE (MRK) KNEE SYSTEM
• Common Device Name: MEDIAL ROTATION KNEE LEFT TIBIA
• Manufacturer (Section D): MATORTHO; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8526375
• Report Number: 3008985661-2019-00004
• Device Sequence Number: 11233835
• Product Code: JWH
• UDI-Device Identifier: 05055455503717
• UDI-Public: 05055455503717
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K020214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2019

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 Catalogue Number: 156-513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/18/2019
• 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