MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	74027264
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to the patient been unstable; a thicker insert was implanted.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation indicated that this complaint from the united states reports a revision of a journey ii knee secondary to ¿joint instability¿.To correct the issue ¿a thicker insert was implanted¿ no clinical/medical documents have been provided for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.A review of the device history 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 complaint history for the listed part 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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as articular surface geometry, overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 12MM
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9558930
• Report Number: 1020279-2020-00153
• Device Sequence Number: 2283394
• Product Code: JWH
• UDI-Device Identifier: 00885556178119
• UDI-Public: 00885556178119
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 10/15/2020

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: 74027264
• Device Catalogue Number: 74027264
• Device Lot Number: 17KM07430
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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: 45 YR