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

Model Number	74021164
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka had been performed, the clinical subject experienced a loose femoral component.Treatment has not been provided for this damage/ disability, so the event is ongoing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was reported that the patient presented with a loose left femoral component (ae#3) approximately 2 years post implantation with onset 01/29/2021 per crf documentation.The severe ae was noted as possibly related to the study device and definitely related to the procedure per datafax#047, plate#100; however, no actions were taken at that time and the outcome was not recovered/not resolved.The ae (#3) follow-up dated (b)(6) 2021 (datafax#47, plate#101) showed actions taken were surgery/procedure, revision, and hospitalization with a ¿recovered/resolved¿ outcome with the patient being discontinued due to the event due to (sae#3, plate#103) diagnostic report/¿bone scan reveals loose femoral component¿ of left tk.The root cause of the reported loosening noted on bone scan could not be confirmed or concluded.Patient impact beyond the reported sae/loosening of the left femoral component and revision procedure could not be determined as the component was reportedly ¿explanted at outside facility¿ and the patient was removed from the study.Of note, the event was documented as a "disability or permanent damage", however, the "required intervention to prevent impairment or damage" entry was also checked to note the revision.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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 the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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 abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11540461
• Report Number: 1020279-2021-02256
• Device Sequence Number: 3095397
• Product Code: JWH
• UDI-Device Identifier: 00885556422793
• UDI-Public: 00885556422793
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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: 74021164
• Device Catalogue Number: 74021164
• Device Lot Number: 18KM01023
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71932636/GEN II 7.5MM RESUR PAT 32MM/18LM18695; 74022203/JRNY II XR BASEPLATE SZ 3 LT/16GSL0010C; 74023741/JRNY II XR INS XLPE MED 3-4 LT 9MM/16FM13; 74023841/JRNY II XR INS XLPE LAT 3-4 LT 9MM/UNKNOW; 71932636/GEN II 7.5MM RESUR PAT 32MM/18LM18695; 74022203/JRNY II XR BASEPLATE SZ 3 LT/16GSL0010C; 74023741/JRNY II XR INS XLPE MED 3-4 LT 9MM/16FM13; 74023841/JRNY II XR INS XLPE LAT 3-4 LT 9MM/UNKNOW
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR