MAUDE Adverse Event Report: MATORTHO LIMITED SAIPH KNEE; SAIPH® FIXED TIBIAL BEARING BLUE RIGHT SIZE C 10MM

Catalog Number	193-754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A notification was received stating; "right tibial bearing implanted along with left tibial tray & femur in left tkr case." the usage sheet was communicated by the agent after the primary case was completed to matortho.The sales agent was informed immediately by the matortho employee that an incorrect poly has been implanted during the surgery.The surgeon, hospital staff and patient were then made aware of this error and the surgeon decided to perform revision surgery on the following day.The patient was kept in hospital and revision surgery was performed on (b)(6) 2019.The procedure was successfully completed; they explanted the incorrect poly and the correct poly was then implanted (part number 193-748, left tibial bearing blue size c 10mm, lot # 224955, exp: 01/09/2028).A review of the device history record for part number 193-754 (saiph fixed tibial bearing blue right size c 10mm) implanted on (b)(6) 2019 and the corrected implant ((b)(6) 2019) part number 193-748 ((b)(6) fixed tibial bearing blue left size c 10mm, lot # 224955, exp: 2028-09-01) did not identify any issues, no non-conforming product was released.
Event or Problem Description
A notification was received stating that a left tkr case was performed on (b)(6) 2019 where an incorrect tibial insert (right) was used.Another surgery was performed on (b)(6) 19 to remove the incorrect tibial insert implanted on the (b)(6) 2019 and implant a correct tibial insert.(b)(4).

• Brand Name: SAIPH KNEE
• Common Device Name: SAIPH® FIXED TIBIAL BEARING BLUE RIGHT SIZE C 10MM
• Manufacturer (Section D): MATORTHO LIMITED; 19/20 mole business park; randalls road; leatherhead, KT22 7BA; UK KT22 7BA
• MDR Report Key: 8775643
• Report Number: 3008985661-2019-00008
• Device Sequence Number: 1937786
• Product Code: JWH
• UDI-Device Identifier: 05055455506756
• UDI-Public: 05055455506756
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: No Information
• Device Catalogue Number: 193-754
• Device Lot Number: 224696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/10/2019
• 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: 77 YR