MAUDE Adverse Event Report: MATORTHO LTD. SAIPH KNEE; SAIPH® FIXED TIBIAL BEARING GREEN RIGHT SIZE E 10MM

Catalog Number	193-802
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A notification was received stating that a revision was required.The patient presented with an unstable knee and "clunking".On (b)(6) 2019 the revision was performed and the saiph® fixed tibial bearing green right size e 10mm was explanted and a saiph fixed tibial bearing size e, right 16mm part number 193-805, lot 202271, expiry 2022-02 was implanted.The procedure was successfully completed.Information provided stated that the patients' medial collateral ligament was possibly damaged during the primary procedure and that the 16mm implanted released the patients iliotibail band.A review of the device history record relating to the manufacture of part number 193-802, saiph® fixed tibial bearing green right size e 10mm, lot 223030, expiry date 2028-02-01 did not identify any issues; no non-conforming product was released.
Event or Problem Description
A notification was received stating "booking for patient needing a change of a e right fixed tibial bearing 10mm due to patient's right knee being unstable." (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH® FIXED TIBIAL BEARING GREEN RIGHT SIZE E 10MM
• Manufacturer (Section D): MATORTHO LTD.; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 9390146
• Report Number: 3008985661-2019-00012
• Device Sequence Number: 381963
• Product Code: JWH
• UDI-Device Identifier: 05055455507234
• UDI-Public: 05055455507234
• 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
• Report Date (Section B): 11/28/2019

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: 193-802
• Device Lot Number: 223030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/28/2019
• 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: 65 YR