MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 1-2 LT 12MM; PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER

Model Number	74027224
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.The patient had itb syndrome.The doctor consider that itb syndrome and pain were not caused by the product.The patient had originally knee valgus.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation, and the reported event could not be confirmed.A review of the device history records for the reported batches 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 complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Although there were no prior complaints for three of the four reported devices.A clinical analysis indicated that this complaint from japan reports a revision of a hip secondary to ¿itb traction syndrome and severe pain¿.Reportedly, ¿the doctor considered that itb syndrome and pain were not caused by the product¿.It was communicated that no clinical/medical documentation or x-rays would be forthcoming for this investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.The risk management file and instructions of use for the product were reviewed.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.If 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.Be re-opened.We consider this investigation closed.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 1-2 LT 12MM
• Common Device Name: PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9714938
• Report Number: 1020279-2020-00558
• Device Sequence Number: 2512971
• Product Code: JWH
• UDI-Device Identifier: 00885556177365
• UDI-Public: 00885556177365
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• 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: 74027224
• Device Catalogue Number: 74027224
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 02/14/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention