MAUDE Adverse Event Report: MATOTHO LTD. SAIPH® KNEE; SAIPH® FIXED TIBIAL BEARING BLUE LEFT SIZE C 12MM

Catalog Number	193-749
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	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notification was received stating that on (b)(6) 2019 mr (b)(6) had performed a second revision on a patient where the poly had been replaced.The previous revision was performed on (b)(6) 2019 where a 30mm patella was explanted and a 26mm patella was implanted ((b)(4), mfr report 3008985661-2019-00003).On the (b)(6) 2019 part number 193-749 was explanted and part number 193-750 saiph® fixed tibial bearing blue left size c 14mm, lot 207812, expiry date 2024-01-01 was successfully implanted.The device history record relating to the manufacture of part number 193-749, lot 213401 was reviewed which confirmed that no nonconforming product was released.The investigation has not identified a definitive root cause; however a 14mm bearing was implanted which could infer that the joint was loose / unstable, but this has not been stated.
Event or Problem Description
"2nd revision case was done by mr (b)(6) at (b)(6) private hospital (b)(6) on wednesday, (b)(6) 2019 and poly was replaced.1st revision was done by mr (b)(6) on (b)(6) 2019 and patella was replaced." matortho reference (b)(4).

• Brand Name: SAIPH® KNEE
• Common Device Name: SAIPH® FIXED TIBIAL BEARING BLUE LEFT SIZE C 12MM
• Manufacturer (Section D): MATOTHO LTD.; 19/20 mole business park; randalls road; leatherhead, KT22 7BA; UK KT22 7BA
• MDR Report Key: 9595656
• Report Number: 3008985661-2020-00001
• Device Sequence Number: 3175028
• Product Code: JWH
• UDI-Device Identifier: 05055455506701
• UDI-Public: 05055455506701
• 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: 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: 09/01/2025
• Device Catalogue Number: 193-749
• Device Lot Number: 213401
• 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: 63 YR