MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 8; PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL

Model Number	74022218
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure upon opening the sterile inner packaging, it was noticed the implant had white flakes on it.A duplicate implant was opened and used.No delay reported.
Additional Manufacturer Narrative
H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that during procedure upon opening the sterile inner packaging, it was noticed the implant had white flakes on it.A duplicate implant was opened and used.No delay reported.
Additional Manufacturer Narrative
H3, h6.The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has white residue on the surface.The device was manufactured in 2016.The lab analysis concluded that the tibial component was examined via visual inspection and attenuated total reflection.White material was observed on the surface of the tibial baseplate and is visible.Attenuated total reflection was used to analyze the white material on the surface of the tibial baseplate.Atr identified the white material as low-density polyethylene.The sterile inner packaging was not returned.It is unclear the nature of the reported white material.No material or manufacturing deviations were discovered in this investigation.A review of complaint history for the part number 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.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 revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device had a contaminant present.A potential probable cause could be but not limited to a packaging deficiency.This issue was evaluated through our internal quality process and determined to be isolated at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 8
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMCONSTR,CEMNT,POL/METL/POL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis, tn TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis, tn TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, tn, TN 38116 ; 5123913905
• MDR Report Key: 10617219
• Report Number: 1020279-2020-05047
• Device Sequence Number: 19130825
• Product Code: JWH
• UDI-Device Identifier: 03596010554413
• UDI-Public: 03596010554413
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2026
• Device Model Number: 74022218
• Device Catalogue Number: 74022218
• Device Lot Number: 16AM08244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020; 05/27/2022
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/02/2020; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2016
• 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
• Patient Sex: Unknown