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

Catalog Number	193-602
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Autoimmune Disorder (1732)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Saiph implants were explanted on (b)(6) 2018 and were disposed of by the facility except 193-736, (saiph fixed tibial bearing red left size c 10mm) but this has not yet been returned to the facility.The device history record relating to the manufacture of the saiph implants (190-112 lot 216967 exp 08/2026; 193-003 lot 216718 exp 08/2026; 193-602 lot 216906 exp 08/2026 and 193-736 lot 215307 exp 03/2026) have been reviewed and did not identify any non-conformities.When further information is available an additional report will be submitted.
Event or Problem Description
A notification was received at matortho leatherhead on (b)(6) 2018 from matortho australia pty.Stating that a saiph revision had occured on (b)(6) 2018.The patient required revision total knee arthroplasty.The tibial component was loose and had submerged.All implants were explanted and an alternative knee system was required.Matortho reference: (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL TRAY CEMENTED SIZE C
• Manufacturer (Section D): MATORTHO; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 7946266
• Report Number: 3008985661-2018-00001
• Device Sequence Number: 427822
• Product Code: JWH
• UDI-Device Identifier: 05055455506176
• UDI-Public: 5055455506176
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 08/01/2026
• Device Catalogue Number: 193-602
• Device Lot Number: 216906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 10/09/2018
• 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: 71 YR