MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74025625
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to wear.The insert was exchanged.Patient presented via xray and physical exam as unstable.They went in and found that the medial side of her poly was worn.They replaced it with a 1-2 dished 15mm insert.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A lab analysis was conducted and the returned device was examined visually to confirm the stated failure.No destructive analysis was performed.Damage/deformation was observed on the articular surface of the insert.The non-articulating surface of the insert is also damaged and scratched.Burnishing was observed on the articular surface of the insert.No material or manufacturing deviations were observed in this investigation.A clinical evaluation was conducted and the x-rays provided show the medial shifting of the femoral component over the tibia insert.The root cause could be joint laxity vs subject weight or loading of the medial surface more leading to increased wear.Based on the limited information provided the root cause of the reported wear on the insert cannot be confirmed.The impact to the patient beyond the revision cannot be concluded.No further clinical assessment is warranted at this time.Some potential probable causes of the event could include, laxity in the joint or improper loading.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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 ISRT XLPE LT SZ 1-2 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9235254
• Report Number: 1020279-2019-03730
• Device Sequence Number: 2589033
• Product Code: JWH
• UDI-Device Identifier: 00885556422632
• UDI-Public: 00885556422632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 08/17/2025
• Device Model Number: 74025625
• Device Catalogue Number: 74025625
• Device Lot Number: 15HM13915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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
• Patient Age: 59 YR
• Patient Weight: 100