MAUDE Adverse Event Report: MATORTHO SAIPH KNEE; SAIPH FIXED TIBIAL BEARING RED LEFT C 14MM

Catalog Number	193-738
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Saiph revision surgery was performed on (b)(6) 2018 where the 14mm saiph fixed tibial bearing (193-738) was replaced.The device history record relating to the manufacture of saiph fixed tibial bearing red left size c 14mm lot 213268, expiry 01aug2025 has been reviewed and did not identify any non-conformances.If additional information becomes available, a further report will be submitted.
Event or Problem Description
Notification was received stating "surgical case reported to or with hyperflexed knee" and that revision surgery for part # 193-738 saiph fixed tibial bearing c left 14mm lot#213268 (exp 01/08/2025) implanted on (b)(6) 2016 was being performed.(b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FIXED TIBIAL BEARING RED LEFT C 14MM
• Manufacturer (Section D): MATORTHO; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 8247313
• Report Number: 3008985661-2019-00001
• Device Sequence Number: 1582561
• Product Code: JWH
• UDI-Device Identifier: 05055455506596
• UDI-Public: 5055455506596
• 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): 01/14/2019

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: 08/01/2025
• Device Catalogue Number: 193-738
• Device Lot Number: 213268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/15/2019
• 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