MAUDE Adverse Event Report: MATORTHO LTD MEDIAL ROTATION KNEE; MEDIAL ROTATION KNEE FEMORAL COMPONENT PEGGED LEFT F2

Catalog Number	156-012
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information relating to the primary mrk implant has been requested.The bespoke and the explant have also been requested back for investigation.The device history record relating to the manufacture of the bespoke has been reviewed ((b)(4)) and did not identify any non-conformancies.Note: the bespoke is not registered within the u.S.When further information is available, an additional report will be submitted.No mrk product is currently supplied within the u.S.
Event or Problem Description
A notification was received stating that an mrk¿ size 2 femur (and bespoke guides for case (b)(4)) (left) was revised to a hinged knee within 1 month of the primary operation.The primary operation date was reported to be (b)(6) 2017.It was stated that osteophytes prevented proper fitting of a bespoke femoral guide.With application of force, the guide was fitted to the patient anatomy and appeared to fit securely despite a fracture [of the guide] at the top right.The procedure was continued with the bespoke having guided the cutting guide positions, however the anterior femoral cut introduced a large notch.(b)(4).

• Brand Name: MEDIAL ROTATION KNEE
• Common Device Name: MEDIAL ROTATION KNEE FEMORAL COMPONENT PEGGED LEFT F2
• Manufacturer (Section D): MATORTHO LTD; 13 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 6584873
• Report Number: 3008985661-2017-00004
• Device Sequence Number: 92249
• Product Code: JWH
• UDI-Device Identifier: 05055455503397
• UDI-Public: 5055455503397
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K020214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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: 156-012
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/23/2017
• 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: 67 YR