MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 2; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71422432
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision was performed due to the patient developing patella-femoral pain.The patient had a uni replacement done.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, reportedly, a revision surgery was performed due to patella-femoral pain.The date of implantation is unknown.Per communication, the patient had a uni replacement done.One x-ray photo was provided for review but it does not indicate a reason for the patella femoral pain.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided the root cause of the reported patella-femoral pain could not be determined.Progression of disease cannot be ruled out.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch for 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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Pain is potential complications associated with any surgery.Some potential probable causes of this event could include patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.

• Brand Name: JRNY UNI TIBIAL BASE RM/LL SZ 2
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9511324
• Report Number: 1020279-2019-04561
• Device Sequence Number: 11282800
• Product Code: HSX
• UDI-Device Identifier: 00885556088197
• UDI-Public: 00885556088197
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 02/25/2024
• Device Model Number: 71422432
• Device Catalogue Number: 71422432
• Device Lot Number: 14BM20950
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/16/2020
• 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