MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH KNEE; SAIPH® FIXED TIBIAL BEARING RED RIGHT SIZE C 14MM

Catalog Number	193-744
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Disorder (2373); Patient Problem/Medical Problem (2688)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the (b)(6) 2019 part number 193-744 was explanted and part number 193-746 saiph® fixed tibial bearing red right size c 18mm, lot 203054, expiry date 2023-01-01 was successfully implanted.The device history record relating to the manufacture of part number 193-744, lot 202468 was reviewed which confirmed that no nonconforming product was released.The patient presented with "hyperflexed knee" and an 18mm bearing was implanted which could infer (after 6 years 7 months in situ) that the cause of this notification was that the joint had become loose / unstable.
Event or Problem Description
"revision right knee (saiph) was done by mr (b)(6) at the (b)(6) hospital on tuesday, (b)(6) 2019." (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH® FIXED TIBIAL BEARING RED RIGHT SIZE C 14MM
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 9595657
• Report Number: 3008985661-2020-00002
• Device Sequence Number: 19626954
• Product Code: JWH
• UDI-Device Identifier: 05055455506657
• UDI-Public: 05055455506657
• 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: 2013
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: 03/01/2022
• Device Catalogue Number: 193-744
• Device Lot Number: 202468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/16/2020
• 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: 56 YR