MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74027271
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complaint of pain.A revision surgery was performed and the jrny ii bcs xlpe art isrt sz 7-8 rt 9mm was swapped out.There was no loosening.No delay for this event.The patient outcome is improved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that the patient complaint of pain.A revision surgery was performed and the jrny ii bcs xlpe art isrt sz 7-8 rt 9mm was swapped out.There was no loosening.No delay for this event.The patient outcome is improved.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows damage on the lock detail.Scratches are observed on the surface of the device.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A clinical evaluation noted that the revision was up sized to an 11mm from a 9mm.It was communicated that the requested medical documentation would not be provided for inclusion in a medical investigation.Reportedly, the patient status is improved post revision.Based on the information provided, the root cause of the pain could not be definitively concluded; however, reportedly upsizing the thickness of the articulating insert resulted in improvement.The patient impact beyond the reported pain and subsequent revised/upsized insert could not be determined.No further medical assessment can be rendered at this time.Some potential causes of the reported event could include but are not limited to size of device or surgical technique used.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10775595
• Report Number: 1020279-2020-06057
• Device Sequence Number: 19114142
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 74027271
• Device Catalogue Number: 74027271
• Device Lot Number: 17HM20933
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention