MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74024925
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a cori assisted tka surgery had been performed on (b)(6) 2022, the patient experienced a wound dehiscence on left knee.This adverse event was treated by a joint puncture on (b)(6) 2022.Current health status of patient is unknown.It is possible that any of the components of the real intelligence cori may have caused or contributed to the dehiscence, or may have been a general complication of cori-enabled surgery.
Additional Manufacturer Narrative
B5, d1, d2, d4, d6a, d6b, d10, g4, h6.
Event or Problem Description
It was reported that, after a cori assisted tka surgery had been performed on (b)(6) 2022, the patient experienced a wound dehiscence on left knee.This adverse event was treated by a joint puncture on (b)(6) 2022 and with a revision surgery to perform a debridement and exchange the jrny ii bcs xlpe art isrt sz 3-4 lt 10mm on (b)(6) 2022.The event is resolved.
Additional Manufacturer Narrative
B5, d1, d2, d4, d6a, d6b, d10, h6.
Event or Problem Description
It was reported that, after a cori assisted tka surgery had been performed on (b)(6) 2022, the patient experienced a wound dehiscence on left knee.This adverse event was treated by a joint puncture on (b)(6) 2022 and with a revision surgery to perform a debridement and exchange the jrny ii bcs xlpe art isrt sz 3-4 lt 10mm on (b)(6) 2022.The event is resolved.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a left knee joint puncture was followed by a left knee articular insert revision along with wound debridement approximately 6-weeks post implantation due to increased wound dehiscence of distal surgical scar.Initial date of adverse event onset documented as (b)(6) 2022.The provided clinical report forms document the moderate unanticipated adverse event as serious, possibly related to the device and/or procedure with outcome as resolved with an end date of (b)(6) 2022.Although wound dehiscence is a known surgical complication, the clinical root cause of the reported increased wound dehiscence which resulted in the subsequent joint puncture and revision with debridement could not be definitively concluded.The patient impact beyond the reported events could not be determined; however, the outcome is documented as resolved.No further medical assessment could be rendered at this time.A review of the production order 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 listed device.A review of the instructions for use documents for knee systems revealed that skin sloughs or delayed wound healing has been identified as possible adverse effects.A review of the risk management file 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 this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a left cori assisted tka was performed on (b)(6) 2022, on (b)(6) 2022 the patient experienced increasing wound dehiscence in the area of the distal surgical scar.On (b)(6) 2022 the patient was hospitalized, and a joint puncture and a secondary suture were performed; resolving the issue the same day.Nevertheless, then, on (b)(6) 2022 a revision surgery was performed to change the journey ii bcs xlpe articular insert size 3 4 left 10mm and a debridement was performed.By (b)(6) 2022 the patient was discharged.Patient's current health status is unknown.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM
• 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: 15535455
• Report Number: 1020279-2022-04259
• Device Sequence Number: 20772324
• Product Code: JWH
• UDI-Device Identifier: 00885556177662
• UDI-Public: 00885556177662
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/27/2024

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: 74024925
• Device Catalogue Number: 74027242
• Device Lot Number: 21MM16247
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 09/21/2022; 09/21/2022; 10/28/2022; 11/14/2024
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/27/2022; 10/28/2022; 11/08/2022; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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: JOURNEY TIBIA BASE NP LT SZ 3, LOT#:20JM13351; JRNY II BCS FEM COCR LT SZ 5, LOT#: A2123196; JRNY II BCS FEM COCR LT SZ 5, LOT#: A2123196; JRNY II BCS XLPE ART ISRT SZ 3-4 LT 10MM, LOT#:21M; ROB10024, SN:SN00098
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female