MAUDE Adverse Event Report: MATORTHO LIMTED SAIPH KNEE; SAIPH FEMUR CEMENTED BLUE RIGHT SIZE 6

Catalog Number	193-030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of patient (b)(6) confirmed that part number 193-030 saiph femur cemented blue right size 6 (batch number 203044) along with part number 193-790 saiph fixed tibial bearing blue right size e 10mm (batch number 204191) and part number 193-604 saiph fixed tibial tray cemented size e (batch number 205992) were originally implanted in (b)(6) 2014.A review of the device history records confirmed that all product was released to specification, no non-conforming product was released.A number of follow up requests have been made to obtain further information but no information has been provided.It was stated that a competitors / alternative product was used during the revision procedure.Matortho records confirm that no product was supplied specifically for patient (b)(6) at the time of the revision procedure.It was identified that this reportable revision had not been reported to the fda at the time whilst reviewing other matortho notifications.Matortho is correcting this oversight.
Event or Problem Description
"patient specific mould for the fem had the distal block pin holes in the wrong position causing the rest of the cutting blocks to be malpositioned.Fem was recut to counter the malpositioning but the result was not ideal." (b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH FEMUR CEMENTED BLUE RIGHT SIZE 6
• Manufacturer (Section D): MATORTHO LIMTED; 19/20 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• MDR Report Key: 9150060
• Report Number: 3008985661-2019-00010
• Device Sequence Number: 19512421
• Product Code: JWH
• UDI-Device Identifier: 05055455506121
• UDI-Public: 05055455506121
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 140222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 193-030
• Device Lot Number: 203044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2016
• Initial Report FDA Received Date: 10/03/2019
• 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: 53 YR