MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S5-6RM/LL11MM; PROST, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLY

Model Number	71422268
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who had surgery on (b)(6) /2019, was rehabilitating well with minimal pain.However, when walking down a slope, the patient slipped and fell, having an immediate onset of knee pain and catching.The x-rays revealed poly had flipped out of the tibial tray.Revision surgery was performed and during the procedure, femoral and tibial components were well fixed.Poly was loose and not sitting in the tibial tray as expected and explanted.The surgeon also elected to explant the tibial tray, recut the tibial with more slope to improve flexion space and loading.He re-implanted the same size tibial tray and inserted a size 11 poly.
Additional Manufacturer Narrative
The associated devices, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices have signs of damage from implantation and extraction.The devices were manufactured in 2018 and 2019.The medical investigation concluded that, without the relevant clinical information, revision report and the post implantation x-rays, we are unable to determine if the loosening of the poly occurred as the result of the fall or due to the possibility of initial improper positioning of the implant.The impact to the patient beyond the reported fall, pain, catching and revision cannot be determined.Should any additional medical information be provided this complaint will be re-assessed.A dimensional inspection was attempted on the insert but it was too damaged to obtain accurate measurements.The dimensional inspection of the tibial base found it to be within specification.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include a traumatic injury or improper surgical technique.

• Brand Name: JOURNEY UNI TIBINRT S5-6RM/LL11MM
• Common Device Name: PROST, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9728096
• Report Number: 1020279-2020-00635
• Device Sequence Number: 16689203
• Product Code: HSX
• UDI-Device Identifier: 03596010582270
• UDI-Public: 03596010582270
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 04/07/2022
• Device Model Number: 71422268
• Device Catalogue Number: 71422268
• Device Lot Number: 12DM04452
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4),JRNYUNITIBIALBASERM/LLSZ5
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention