MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS FEMORAL OXIN RT SZ 3; PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER

Model Number	74022113
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/11/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject suffered from failure to progress with flexion.The event was treated via manipulation under anesthesia and was resolved.
Additional Manufacturer Narrative
H3, h6: 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 clinical study adverse event form reports a manipulation under anesthesia due to right knee stiffness.The requested x-rays and surgical reports have not been provided to date.Therefore, based on limited information, no further assessment can be performed at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated at that time.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.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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 BCS FEMORAL OXIN RT SZ 3
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBIAL,SM-CNSTRAIND,CMNTD,POLYMER/MTL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10538604
• Report Number: 1020279-2020-04597
• Device Sequence Number: 3872898
• Product Code: JWH
• UDI-Device Identifier: 00885556169810
• UDI-Public: 00885556169810
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 01/14/2022
• Device Model Number: 74022113
• Device Catalogue Number: 74022123
• Device Lot Number: 12AM09059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 06/22/2021
• 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: Required Intervention