MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM; PROSTHESISKNEPATELOFEMOROTIBIALSMICONSTRAINEDCMNTDPOLYMRMETALPOLYMR

Model Number	74027231
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a dislocation.The insert was removed.
Additional Manufacturer Narrative
The devices, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the stated failure.A review of the device history records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts 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 document for this failure mode was conducted and concluded this failure mode has been identified.Our lab concluded, on the returned insert component, abrasion patterns and scratches were observed on the distal surface, and material deformation was observed along the locking mechanism.The root cause of the reported failure mode cannot be confirmed with the available data.No material or manufacturing deviations were observed in the process of this investigation.Our clinical / medical team noted: per subsequent email, no relevant clinical information will be provided.Without the requested clinical information a thorough medical investigation cannot be rendered.Should any additional medical information be provided this complaint will be re-assessed.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM
• Common Device Name: PROSTHESISKNEPATELOFEMOROTIBIALSMICONSTRAINEDCMNTDPOLYMRMETALPOLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9495372
• Report Number: 1020279-2019-04509
• Device Sequence Number: 16604115
• Product Code: JWH
• UDI-Device Identifier: 00885556179017
• UDI-Public: 00885556179017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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 Model Number: 74027231
• Device Catalogue Number: 74027231
• Device Lot Number: 19BM18968
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 11/16/2020
• 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: PART NUMBER 71932635/ LOT NUMBER 19EM10057.; PART NUMBER 74022113/ LOT NUMBER 19HM01575.; PART NUMBER 74022213/ LOT NUMBER 19GM15267.; PART NUMBER 71932635/ LOT NUMBER 19EM10057; PART NUMBER 74022113/ LOT NUMBER 19HM01575; PART NUMBER 74022213/ LOT NUMBER 19GM15267
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 45