MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Muscle Weakness/Atrophy (1967); Discomfort (2330); Implant Pain (4561)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, after a tka surgery had been performed on (b)(6) 2021, the patient has had unspecified symptoms associated to cobalt allergy.The patient also reports that 2 manipulation surgeries, 6 months of pt, and pain blockers put in post surgery made her lose quad muscle for almost a year.A revision surgery might be required to solve the reported event; both the femur and the patella contain trace amounts of cobalt; therefore, it is uncertain which component, if any or both, is causing the reaction.The condition of the patient is ongoing.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a patient reported unspecified symptoms associated to cobalt allergy which may require revision and also underwent 2 manipulation surgeries, 6 months of pt, and post-op pain blockers which ¿made her lose quad muscle for almost a year¿.It was communicated that it has been a ¿10 month terrible journey¿ post-implantation and ¿fighting for¿life¿; however, the requested medical documentation has not been provided as of the date of this medical investigation.Without the requested information, the clinical root cause of the reported events could not be fully assessed or concluded.Although cobalt is identified as in trace amounts, the source could not be confirmed, and neither could the alleged cobalt allergy be ruled out as a possible contributing factor to the reported events.The patient impact beyond the reported symptoms could not be determined.It is unknown if a revision has been medically indicated, planned and/or scheduled.No further medical assessment could be rendered at this time.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 complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, wear, injury, patient condition, joint tightness, traumatic injury, abnormal motion over time or patient reaction.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.

• Brand Name: JRNY II CR FEM OX NP LT SZ 4
• 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: 12701322
• Report Number: 1020279-2021-07683
• Device Sequence Number: 20009619
• Product Code: JWH
• UDI-Device Identifier: 03596010554314
• UDI-Public: 03596010554314
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2021

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: 74022223
• Device Catalogue Number: 74021164
• Device Lot Number: 19EM10473G
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2019
• 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: 74022223-JOURNEY TIBIA BASE NP LT SZ 3; 74025641-JRNY II CR ISRT XLPE LT SZ 3-4 9MM
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Female