MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH KNEE; SAIPH FIXED TIBIAL TRAY CEMENTED SIZE C

Catalog Number	193-602
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notification was received that a saiph revision left knee was planned for (b)(6) 2019.Information was provided on (b)(6) 2019 which stated that the implants were explanted and a revision system from another company was implanted.It was stated that the revision was required due to tibial rotation.The device history record relating to the manufacture of part number 193-602, lot 224553 was performed which confirmed that no nonconforming product was released.
Event or Problem Description
A notification was received stating that a revision left knee (saiph) was planned for (b)(6) 2019.(b)(4).
Event or Problem Description
A notification was received stating that a revision left knee (saiph) was planned for (b)(6) 2019.(b)(4).
Additional Manufacturer Narrative
Notification was received that a saiph revision left knee was planned for (b)(6) 2019.Information was provided on (b)(6) 2019 which stated that the implants were explanted and a revision system from another company was implanted.It was stated that the revision was required due to tibial rotation.The device history record relating to the manufacture of part number 193-602 lot 224553 was performed which confirmed that no non-conforming product was released.During the investigation it was identified that a possible contributing factor was a patient specific guide which had been used, supplied by kico knee innovation company pty ltd.An investigation response was supplied by kico on (b)(6) 2019 to matortho where they concluded "based on available objective evidence of inspection documents, training records of operators, guide design investigation and distribution of the psg.Kico is unable to identify any instances where an over resection can be attributed to design or intended use of the kico psg." the investigation has concluded that the revision was possibly due to intraoperative errors i.E.User error.

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL TRAY CEMENTED SIZE C
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8694843
• Report Number: 3008985661-2019-00006
• Device Sequence Number: 2275434
• Product Code: JWH
• UDI-Device Identifier: 05055455506176
• UDI-Public: 05055455506176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 193-602
• Device Lot Number: 224553
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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
• Patient Age: 62 YR