MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025611
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to patient pain.During revision surgery, it was confirmed that the insert was disassociated from a baseplate.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A lab analysis performed on the part indicated that wear of the articular surface may have been caused by third-body particulate (bone chips, bone cement, etc.) or during removal of the implant.Damage to the inferior surface and posterior lock detail could have been caused by the insert riding the lock detail following disassociation.The deformation seen on the insertion tool anterior divots may have occurred during insertion of the articular insert.If this deformation occurred during insertion of the insert, the deformation may have prevented the insert from fully seating in the lock, but that could not be determined from the information provided.No material or manufacturing defects were observed during this investigation.A clinical investigation concluded that no relevant supporting clinical information will be provided, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of complaint history revealed no prior complaints for the listed batch for the same failure.A review of the manufacturing records did not reveal any deviations that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 1-2 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7238789
• Report Number: 1020279-2018-00112
• Device Sequence Number: 13477676
• Product Code: JWH
• UDI-Device Identifier: 00885556422748
• UDI-Public: 00885556422748
• Combination Product (Y/N): N
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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 Catalogue Number: 74025611
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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
• Patient Age: 60 YR