MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIVACIT-E ART SURF SZ 4 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	00584209408
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 3 years one (1) vivacit-e art surf sz 4 8mm was worn through by the patient.The device was explanted on (b)(6) 2022, in addition to one (1) zuk uni tib base sz 4 rm/ll and one (1) zuk uni femoral size d rm/ll.The procedure was resumed, without any delay, using a competitor device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The devices were returned and evaluated.A visual inspection of the returned device did confirm the stated failure mode.The device is severely worn.An analysis performed to the rest of the components was made.They were inspected visually to determine the cause of the reported incident.No destructive analysis was conducted during this investigation.The insert is worn down and fractured on the outer rounded side with discoloration.The tibial baseplate is worn with scratches.The femoral component is worn and fractured on the articulating surface.The femoral component and tibial baseplate still have bone cement adhered to the bone contacting surfaces.There were no observations of material or manufacturing deviations in the course of this investigation.The clinical investigation concluded that based on a review of the information provided, the reported wear was confirmed by the visual inspection.However, without the requested clinical information the definitive root cause of the reported wear three years post-implantation cannot be determined.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded, since the patient was revised to a competitor¿s device.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.An assessment made by a quality engineering team there were no observations of material or manufacturing deviations in the course of this investigation.An historical review concluded that there are no prior actions related to these products and event.A review of the instructions for use was performed, and the knee systems reveal in possible adverse effects that wear of the polyethylene articulating surfaces of knee replacement components has been reported following total knee replacement.Higher rates of wear may shorten the useful life of the prosthesis, and lead to early revision surgery to replace the worn prosthetic components.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.For the vivacit-e art surf sz 4 8mm, a review of complaint history for the part numbers over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the rest of the components, a review of complaint history for the part numbers over the past 12 months, did not reveal similar events for the listed device.A review of the manufacturing records of the vivacit-e art surf sz 4 8mm did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As the batch number was not available for the rest of the components, the review of the manufacturing records could not be performed.The root cause of the reported event could not be concluded, however, factors that could potentially contribute are abnormal loading of the limb or motion over time and traumatic injury.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VIVACIT-E ART SURF SZ 4 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15946335
• Report Number: 1020279-2022-04914
• Device Sequence Number: 7341233
• Product Code: HSX
• UDI-Device Identifier: 00885556620991
• UDI-Public: 00885556620991
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00584209408
• Device Catalogue Number: 00584209408
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZUK UNI FEMORAL SIZE D RM/LL; ZUK UNI TIB BASE SZ 4 RM/LL
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male