MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74022117
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to aseptic loosening.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that this complaint reported a revision of a right knee secondary to ¿aseptic loosening¿.It was reported in the revision operative notes; ¿the patient had significant worsening of pain in his knee and proximal tibia following the knee replacement and we did an extensive work up, ruling out infection, obtaining a bone scan which showed increased signal uptake in the tibial component.¿ all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.The impact to the patient beyond the additional surgery cannot be determined.No report on the patient¿s current condition was provided.The root cause of the ¿aseptic loosening¿ cannot be concluded with the available information.Aseptic loosening is the failure of the bond between an implant and bone in the absence of infection.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.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.Some potential probable causes for this event could include improper fit/sizing or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, these complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 7
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9235239
• Report Number: 1020279-2019-03728
• Device Sequence Number: 2388054
• Product Code: JWH
• UDI-Device Identifier: 00885556170014
• UDI-Public: 00885556170014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 74022117
• Device Catalogue Number: 74022117
• Device Lot Number: 16LM14640
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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