MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 7 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Insufficient Information (4580)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, after a tka was performed on (b)(6) 2018, the patient experienced an unknown problem that led to a revision surgery on (b)(6) 2022.Current health status of patient is unknown.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b7, d10, e1 corrected data: b1, b5, g2, h6 (health effect - clinical code).
Event or Problem Description
It was reported that, after a left bicruciate retaining tka surgery was performed on (b)(6) 2018, the patient developed pain and instability.This was treated on (b)(6) 2022 by performing a revision surgery, where it was determined that the patient had an anterior cruciate ligament (acl) rupture.The surgeon decided to keep the femoral and patellar components and only revise the tibial component and the inserts.Patient was taken to the recovery room in stable condition.Patient has stated that is still having issues with the knee.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that no clear causal relationship between the alleged event and the devices could be determined.The clinical root cause of the reported pain and instability was due to the anterior cruciate ligament (acl) rupture.Per the revision operative report findings, ¿the joint was made unstable by the acl rupture.¿ it is unknown if the patient¿s reported fall at 10 weeks post operation and lack of physical therapy for a period of one month cannot be ruled out as possible contributing factors to the reported adverse event.During revision the femoral, tibial, and patella components were all found to be well fixed with no evidence of infection per the (b)(6) 2022 revision operative report.Additionally, the patient was transferred to the recovery in stable condition; however, ¿still having issues with knee.¿ the patient impact beyond the reported pain, instability, acl rupture and subsequent revision cannot be determined.Therefore, no further clinical/medical assessment can be rendered.For the baseplate and inserts, 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 numbers over the past 12 months and for the batch numbers based on historical data of the devices did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed that postoperative care should be taken as the acl may be damaged.Besides, postoperative therapy should be structured to prevent excessive loading of the operative knee.This has been identified in warnings and precautions.A review of the risk management files is not applicable because no information was provided that relates the failure mode to the device.A historical review concluded that there are no prior actions related to these products and event.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 traumatic injury, patient condition and/or abnormal loading of limb.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.

• Brand Name: JRNY II XR BASEPLATE SZ 7 LT
• 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: 16935011
• Report Number: 1020279-2023-01048
• Device Sequence Number: 6235552
• Product Code: JWH
• UDI-Device Identifier: 00885556615379
• UDI-Public: 00885556615379
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2023

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: 74022207
• Device Catalogue Number: 74022207
• Device Lot Number: 17ASL0012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 06/07/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2017
• 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: 71421035/18AM06000/GII OVAL RESURFACING PAT 35MM; 74021268/B1708198/JRNY II CR FEM COCR NP LT SZ 8; 74023780/16BM15976/JRNY II XR INS XLPE MED 7-8 LT; 74023880/16BM16074/JRNY II XR INS XLPE LAT 7-8 LT
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 106 KG