MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74021163
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/03/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2015 due to instability of the implant in patient's left knee.The femoral component and the insert were explanted.The outcome of the event is resolved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this retrospective study reports a left tka revision due to instability.Without supporting pre and post-implantation radiographs, operative reports and/or the analysis of the explanted components, the root cause of the reported revision cannot be confirmed, and it cannot be concluded that the reported instability was associated with a mal-performance of the implant.The patient impact beyond the revision and associated post-op pain cannot be determined, and there is no report of the patient¿s current condition, or whether the reported clinical symptoms persist.No further medical assessment is warranted at this time.Should clinically relevant documentation/ information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited fit/sizing, alignment, surgical technique, joint laxity, traumatic injury and procedural/user error.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.Without the actual product involved and/or device information, our investigation cannot proceed.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 CR FEM OX NP LT SZ 3
• 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: 10468818
• Report Number: 1020279-2020-04279
• Device Sequence Number: 2553227
• Product Code: JWH
• UDI-Device Identifier: 00885556422809
• UDI-Public: 00885556422809
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 74021163
• Device Catalogue Number: 74021163
• Device Lot Number: 12KM09544A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 06/23/2021
• 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: 74022222, 71420574, UNK STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82