MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 5; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422435
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tibia base was loose and femoral thereby femoral component was severely mechanically damaged.
Additional Manufacturer Narrative
The associated journey uni tibial baseplate, journey uni insert and uni femoral component were returned and evaluated.A lab analysis conducted during this investigation noted that damage was observed on the articular surface of the femoral component and on the lock and superior surface of the tibial base.The damage was likely created by contact between the femoral and tibial baseplate components.Deformation/damage observed on the tibial insert may have been created by third-body particulate (bone, bone cement, etc.) and/or by articulation against the damaged area of the femoral component.No material or manufacturing deviations were discovered in this investigation.A dimensional inspection performed on the baseplate found all features inspected are within specification.However there is noticeable damage to the top of the rail and on the tray surface.Dimensional inspection of the insert cannot be performed as part appears to have been autoclaved.Our investigation including 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 manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted no clinical relevant documents were provided to conduct a thorough medical assessment.The reported cd with x-rays has not been provided.No medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis conducted during this investigation noted that damage was observed on the articular surface of the femoral component and on the lock and superior surface of the tibial base.The damage was likely created by contact between the femoral and tibial baseplate components.Deformation/damage observed on the insert may have been created by third-body particulate (bone, bone cement, etc.) and/or by articulation against the damaged area of the femoral component.A dimensional inspection performed on the baseplate found all features inspected are within specification.However there is noticeable damage to the top of the rail and on the tray surface.Dimensional inspection of the insert cannot be performed as part appears to have been autoclaved.Our investigation including 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 manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted based on the x-ray photos that show the femoral component contacting the tibial component along with the pathology report, the revision surgical findings may be consistent with an adverse reaction to metal debris; however, the source cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The surgeon notes did not reveal any findings of ¿the striking periarticular ossification in the popliteal fossae and suprapatellar¿.The future impact to the patient beyond the revision cannot be determined.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY UNI TIBIAL BASE RM/LL SZ 5
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7644504
• Report Number: 1020279-2018-01215
• Device Sequence Number: 176348
• Product Code: HSX
• UDI-Device Identifier: 00885556088340
• UDI-Public: 00885556088340
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/18/2019

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: 12/15/2025
• Device Catalogue Number: 71422435
• Device Lot Number: 15MM13729
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 06/06/2018; 06/06/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 11/08/2018; 01/09/2019; 01/18/2019
• 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: PART NO. 71422265 / LOT NO. UNKNOWN; PART NO. 71422356 / LOT NO. 16JM02266; UNKNOWN KNEE IMPLANT; UNKNOWN KNEE IMPLANT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR