MAUDE Adverse Event Report: MATORTHO SAIPH KNEE; SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE D 12MM

Catalog Number	193-773
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Saiph revision surgery was performed on (b)(6) 2018 where the 12mm saiph fixed tibial bearing (193-773) was replaced with an 18 mm fixed tibial bearing (193-776).The 12mm bearing has been retained by the facility.It was reported that the procedure was completed successfully.The device history record relating to the manufacture of saiph fixed tibial bearing blue left size d 12mm (193-773, lot 202874 expiry 01may2022) has been reviewed and did not identify any non-conformities.If additional information becomes available than a further report will be submitted.
Event or Problem Description
Notification was received stating that "the patient required revision knee surgery (insert change) post primary tkr.Patient had a fall 6/52 post tkr and ruptured quadriceps muscle.Surgeon performed an arthrotomy but patient still achieving 10 degrees of hyperflexion.Revision tkr was then planned and performed (b)(6) 2018, 12mm insert explanted, 18mm inserted implanted (193-776, lot 201245)".Matortho reference: (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL BEARING BLUE LEFT SIZE D 12MM
• Manufacturer (Section D): MATORTHO; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 7946270
• Report Number: 3008985661-2018-00002
• Device Sequence Number: 16336289
• Product Code: JWH
• UDI-Device Identifier: 05055455506947
• UDI-Public: 5055455506947
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: 05/01/2022
• Device Catalogue Number: 193-773
• Device Lot Number: 202874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/09/2018
• 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: 67 YR