MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN TIB PLY OLAY MAG RM/LL 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71243619
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after procedure, a broken metallic ring was discovered inside patient.No remedial action reported.No procedure, delay, injury or back up reported.
Additional Manufacturer Narrative
The associated genesis ii uni all poly onlay tibial component was not returned for evaluation.A clinical evaluation noted there were no reports of complications during the implantation procedure.No patient information has been provided for this investigation.In a communication, the component or wire is referred to as an ¿iron wire¿.Two x-rays submitted for review appear to show fragments of some sort of wire and it is possible, per the x-ray, that the witness wire is not completely surrounding the implant so the fragments may be pieces of the witness wire.Based on the limited information provided, we cannot confirm the source of the wire but if it is the ¿witness wire¿, it is f-1350 alloy that is implantable and bio-compatible though we cannot conclude if the location of the fragments will impact the knee and if it will cause future harm to the patient.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: GEN TIB PLY OLAY MAG RM/LL 9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8036164
• Report Number: 1020279-2018-02360
• Device Sequence Number: 1302702
• Product Code: HSX
• UDI-Device Identifier: 03596010501738
• UDI-Public: 03596010501738
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 04/27/2024
• Device Catalogue Number: 71243619
• Device Lot Number: 14DM22647
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/03/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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: Hospitalization