MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH KNEE; SAIPH FEMUR CEMENTED RED RIGHT SIZE 3

Catalog Number	193-027
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Information (3190)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notification was received that a saiph revision right knee was planned for (b)(6) 2019.No device investigation is possible at present as the device remains implanted, however a review of the device history record relating to the manufacture of part 193-027 lot 216061 was performed which confirmed that no nonconforming product was released.
Event or Problem Description
A notification was received that a revision of a right knee (saiph) was planned for (b)(6) 2019, (b)(4).
Additional Manufacturer Narrative
Notification was received that a saiph revision right knee was planned for (b)(6) 2019.No device investigation is possible at present as the device remains implanted, however a review of the device history record relating to the manufacture of part 193-027 lot 216061 was performed which confirmed that no nonconforming product was released.On 01oct2019: additional information was received on 26sep2019 which stated that the procedure was performed on (b)(6) 2019.It was reported that the patient had a fall in a trench and an initial tkr arthroscopy did not help the pain and swelling.Surgery performed on (b)(6) 2019 implanted a patella 23mm (190-110 saiph cemented patella 23mm, lot 214468 expiry date 2026-01-01); no device was explanted.It was reported that the patient was feeling better with no complications.
Event or Problem Description
A notification was received stating that a revision of a right knee (saiph) was planned for 08aug2019, per (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FEMUR CEMENTED RED RIGHT SIZE 3
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8694874
• Report Number: 3008985661-2019-00005
• Device Sequence Number: 16762364
• Product Code: JWH
• UDI-Device Identifier: 05055455506091
• UDI-Public: 05055455506091
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 05/01/2026
• Device Catalogue Number: 193-027
• Device Lot Number: 216061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: 61 YR