MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH KNEE; SAIPH CEMENTED PATELLA 30MM

Catalog Number	190-112
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Disorder (2373); Patient Problem/Medical Problem (2688)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Notification was received that a saiph patella revision left knee was planned for (b)(6) 2019.Additional information was requested on (b)(6) 2019.On (b)(6) 2019 it was confirmed that the 30mm patella had been explanted and a 26mm patella 190-111, lot 214300 (exp date 2025-11-01) had been successfully implanted.The device history record relating to the manufacture of part 190-112, lot 216967 was performed which confirmed that no non-conforming product was released.
Event or Problem Description
A notification was received that a patella revision left knee (saiph) was planned for (b)(6) 2019.(b)(4).
Event or Problem Description
A notification was received that a patella revision left knee (saiph) was planned for (b)(6) 2019.(b)(4).
Additional Manufacturer Narrative
Notification was received that a saiph patella revision left knee was planned for (b)(6) 2019.Additional information was requested on (b)(6) 2019 and (b)(6) 2019.On (b)(6) 2019 it was confirmed that the 30mm patella had been explanted and a 26mm patella 190-111 lot 214300 (exp date (b)(6) 2025) had been successfully implanted.The device history record relating to the manufacture of part 190-112 lot 216967 was performed which confirmed that no nonconforming product was released.

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH CEMENTED PATELLA 30MM
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8478302
• Report Number: 3008985661-2019-00003
• Device Sequence Number: 16560072
• Product Code: JWH
• UDI-Device Identifier: 05055455509351
• UDI-Public: 05055455509351
• 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,Followup
• Report Date (Section B): 05/01/2019

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: 08/01/2026
• Device Catalogue Number: 190-112
• Device Lot Number: 216967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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: 63 YR