MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 8; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022118
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, although the external box of the jrny ii bcs femoral oxin rt sz 8 implant was intact, the plastic wrap was not sealed; the implanted came straight in the box.This happened during a tka surgery, but it was noticed on time, so there was not any effect on the operation.There was another prosthesis on stock and it was used after a 2-min delay.Patient was not affected.
Additional Manufacturer Narrative
Section h10: the associated device was returned and evaluated.Visual inspection of the returned device found the plastic wrap was sealed, and all inner packaging components were intact.However, there was a crack in the outer tray of the packaged product.The femoral was not fully exposed upon evaluation of the returned product.The complaint report stated, ¿the implant came straight in the box¿, but after further investigation there is no indication that the product was loose in the carton as all packaging components were whole.A review of complaint history for the part number over the past 12 months and for the batch number 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.A review of the sterilization records revealed the batch was sterilized within normal parameters.A review of the risk management file revealed this failure mode was previously identified and 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.The complaint was confirmed and a contribution of the device to the reported event could be corroborated as the device's packaging was found to be damaged therefore did not meet manufacturing specifications upon evaluation.This event was evaluated through our internal quality process and determined to be isolated at this time.While a definitive root cause could not be identified, potential factors that could contribute to the reported event include an inspection process error or damage due to inappropriate handling during transportation or storage of the device.Currently, there are various visual inspections completed at all operations in the packaging areas to detect these defects.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.Internal complaint reference number: case-(b)(4).

• Brand Name: JRNY II BCS FEMORAL OXIN RT SZ 8
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 14741320
• Report Number: 1020279-2022-03070
• Device Sequence Number: 5800908
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 06/07/2026
• Device Model Number: 74022118
• Device Catalogue Number: 74022118
• Device Lot Number: 16FM07641B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 06/19/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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