MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI COCR FB FEM SZ 2 RM LL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422372
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a journey unicompartimental surgery was performed on the (b)(6) 2016, the patient complained of knee pain, feeling discomfort during daily standard activities and having moderate problems when walking.A possible lateral compartment meniscal tear of the right knee was diagnosed on the 05-oct-2018.Rest was advised and a corticosteroid injection was provided.The event was not resolved through out the following visits and on the (b)(6) 2021 the patient was referred for an arthroscopy.The implants remained in place at that time.Patient's outcome is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.Based on the information provided, the unsatisfactory experience could be confirmed.The clinical/medical investigation concluded that, based on the limited information provided in the study documentation, there were no clinical factors found which would have definitively contributed to the possible lateral compartment meniscal tear and a malperformance of the right j-uni components is not supported.The patient impact beyond that which was reported in the study and adverse event forms cannot be determined.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 device did not reveal similar events for the listed devices.A review of the instructions for use documents for knee systems revealed in warnings and precautions, postoperative section that use extreme care in patient handling is needed and postoperative patient care and directions and warnings to patients by physicians are extremely important.Protected weight bearing with external support is recommended for a period of time to allow healing.Normal daily activity may be resumed at the physician¿s direction.Patients should be directed to seek medical opinion before entering potentially adverse environments that could affect the performance of the implant.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.Based on this investigation, the need for corrective action is not indicated.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.

• Brand Name: JUNI COCR FB FEM SZ 2 RM LL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 18326613
• Report Number: 1020279-2023-02501
• Device Sequence Number: 6970520
• Product Code: HSX
• UDI-Device Identifier: 03596010627520
• UDI-Public: 03596010627520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Catalogue Number: 71422372
• Device Lot Number: 16CM13549
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• 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: A
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG