MAUDE Adverse Event Report: MATORTHO LTD. SAIPH KNEE; SAIPH FIXED TIBIAL BEARING YELLOW RIGHT SIZE A 14MM

Catalog Number	193-708
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	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was experiencing stiffness and reduced flexion.A ct scan did not identify any issues, the components were well fixed and in a good position.No cause could be identified.However, during the surgery on (b)(6) 2019 the surgeon noted and removed scar tissue.This notification is not a device related issue.A 14mm insert part number 193-708, saiph aps fixed tibial bearing yellow right size a, lot 201137, expiry date 2021-12-01 was inserted.The procedure was stated as being completed successfully and that the patient status was as expected.A review of part number 193-708, saiph aps fixed tibial bearing yellow right size a 14mm, lot 201137 expiry date 2021-12-01 did not identify any issues, no non-conforming product was released.
Event or Problem Description
A notification was received stating that a poly exchange had been performed.Matortho reference: (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL BEARING YELLOW RIGHT SIZE A 14MM
• Manufacturer (Section D): MATORTHO LTD.; 19/20 mole business park; randalls road; leatherhead, KT22 7BA; UK KT22 7BA
• MDR Report Key: 9352796
• Report Number: 3008985661-2019-00011
• Device Sequence Number: 3095858
• Product Code: JWH
• UDI-Device Identifier: 05055455506299
• UDI-Public: 05055455506299
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/21/2019

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 Expiration Date: 12/01/2021
• Device Catalogue Number: 193-708
• Device Lot Number: 201137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/21/2019
• 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: 66 YR