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

Model Number	74035271
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while trialing the jrny ii bcs art isrt trl sz 7-8 9mm rt the surgeon had to use a surgical instrument to push the trial into the correct place.The trial wasn¿t sitting inside the tibia like it should, this resulted in the degradation of the journey insert.The insert will no longer click into place properly and is not reliable in terms of patient trialing.A delay of less than 30 min was reported.A s&n back up device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, insert did not seat fully onto the baseplate and became damaged after using an instrument to push it into place.Per complaint details, there was no harm to the patient, and the procedure was completed using a backup device.There was a delay of less than 30-minutes.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures for the listed device; 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 BCS ART ISRT TRL SZ 7-8 9MM RT
• 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: 10775663
• Report Number: 1020279-2020-06060
• Device Sequence Number: 1126425
• Product Code: JWH
• UDI-Device Identifier: 00885556157787
• UDI-Public: 00885556157787
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74035271
• Device Catalogue Number: 74035271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2020
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 11/02/2020
• 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: INSERT UNK PART NUMBER.; INSERT UNK PART NUMBER
• Outcome Attributed to Adverse Event: Required Intervention