MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2022 the patient experienced an infection.A revision surgery was performed on an unknown date to address this adverse event.The surgeon replaced the explanted devices with new tibia component, and a cocr legion femur cemented in with antibiotic cement to help with infection.The patient left the surgical case in good health.No injury to the patient, no delay in case, no further medical history available at this time.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Additional information.
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2022, the patient experienced an infection.A revision surgery was performed on (b)(6) 2023 to solve this adverse event.During the surgery, the whole system was replaced with a new one, and antibiotic cement was used to help with the infection.The patient left the surgical case in good health.No further information is available.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision was performed approximately 13 months post implantation due to an unspecified infection.It was communicated that the details of the primary implantation and laboratory results were not available.Reportedly the whole system was replaced with a new one along with antibiotic cement to help with the infection.Although the current patient status is unknown, reportedly, the patient left the surgical case in good health.Without the requested medical documentation, the source of the reported infection cannot be concluded.The impact to the patient beyond the reported infection and subsequent revision cannot be determined, although adjunctive medication therapy would be anticipated.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 femoral component.A review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data for the tibial baseplate, patella and insert.A review of the instructions for use documents for knee systems revealed that acute post-surgical wound infection and local infection or previous intra-articular infections have been identified as possible adverse effects and contraindications for total knee replacement.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices or 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.H10 ¿ additional information.D6a- if implanted, give date h11 ¿ corrected data.B2- outcomes attributed to adverse event.D10- concomitant medical products.

• Brand Name: JRNY II BCS FEMORAL OXIN RT SZ 7
• 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: 17368096
• Report Number: 1020279-2023-01486
• Device Sequence Number: 3864290
• Product Code: JWH
• UDI-Device Identifier: 00885556170014
• UDI-Public: 00885556170014
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (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): 08/21/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 74022117
• Device Catalogue Number: 74022117
• Device Lot Number: 21HM11464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 08/16/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/01/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2021
• 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: 71421032/GII OVAL RESURFACING PAT 32MM.; 74022216/JOURNEY TIBIA BASE NP RT SZ 6.; 74027252/JRNY II BCS XLPE ART ISRT SZ 5-6 RT 10MM.; GII RSRFCNG PAT32MM(PN:71421032,LN:22CM03988).; JRNY II ISRTSZ 5-6RT10MM(PN:74027252,LN:21KM01841).; JRNY TIB BS RT SZ 6(PN:74022216,LN:21KM07464).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female