MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIBINRT S1-2LM/RL9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71422242
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to tibial fracture and baseplate loosening.All implants were exchanged to legion.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The medical investigation concluded that no clinical relevant supporting documents were provided to conduct a thorough medical assessment of the reported tibial fracture and baseplate loosening.However, a revision procedure was performed to revise the component in which all implants were reported to be exchanged to legion.No further clinical assessment is warranted based on the limited information provided with this case.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 complaint history did not reveal additional complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY UNI TIBINRT S1-2LM/RL9MM
• 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: 8850991
• Report Number: 1020279-2019-02887
• Device Sequence Number: 13843311
• Product Code: HSX
• UDI-Device Identifier: 03596010582058
• UDI-Public: 03596010582058
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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 Catalogue Number: 71422242
• Device Lot Number: 18CM00311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 11/05/2019
• 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