MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JUNI COCR FB FEM SZ 3 LM RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422363
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arthralgia (2355)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after a medial uka surgery, had been performed on (b)(6) 2020, the patient experienced patellofemoral joint pain in the left knee.The patient's outcome has not been resolved, and a hyaluronic acid injection has been scheduled.Further information is not available at this time.
Additional Manufacturer Narrative
Section a2 was updated.Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, approximately 2 years post implantation (and almost 2 yrs post resolution of left knee pain via physical therapy), the patient is scheduled for a hyaluronic acid injection due to mild pfj pain of the left knee which is documented as a mild, non-serious adverse event, possibly related to the device and/or procedure.The provided clinical data-set was reviewed; however, it does not provide insight into a definitive root cause of the reported event.The patient impact beyond the reported ¿pfj pain of the left knee¿ and the scheduled injection cannot be determined.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 based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveal that improper fixation, and/or migration of the components could cause possible adverse effects.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.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.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.Internal complaint reference number: (b)(4).

• Brand Name: JUNI COCR FB FEM SZ 3 LM RL
• 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
• MDR Report Key: 14331928
• Report Number: 1020279-2022-02234
• Device Sequence Number: 19959541
• Product Code: HSX
• UDI-Device Identifier: 03596010627469
• UDI-Public: 03596010627469
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K073175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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
• Device Model Number: 71422363
• Device Catalogue Number: 71422363
• Device Lot Number: 19GBP0047
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG