MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023251
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Discomfort (2330); Joint Laxity (4526)
Date of Event	04/16/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
*us legal* it was reported that, after a tka-bcs construct had been implanted on the plaintiff's right knee on (b)(6) 2009, the plaintiff experienced the fracture of the tibial insert.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the insert was explanted.The plaintiff's outcome is unknown.
Event or Problem Description
It was reported that, after a tka-bcs construct had been implanted on the patient's right knee on (b)(6) 2009 (bilateral patient), the patient experienced the fracture of the tibial insert and synovitis.A revision surgery was performed on (b)(6) 2019 to treat this adverse event; the insert was explanted.The patient was discharged a day later in overall good condition.
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the right insert post-fracture was the root cause of the revision, and although the root cause of the post-fracture could not be definitively concluded, the symptom onset reportedly occurred following ¿a pop in knee¿ during the activity of bending and twisting the knee/¿putting his leg up¿.The assessed patient impact was the instability, clunk, synovitis/synovectomy, post-fracture and insert revision.No further medical assessment could be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated 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 batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JOURN ART INS BCS STD 5-6 RT 9
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12080485
• Report Number: 1020279-2021-05481
• Device Sequence Number: 11629189
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 03596010555137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2016
• Device Model Number: 74023251
• Device Catalogue Number: 74023251
• Device Lot Number: 06HM01646
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 10/07/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/08/2021
• 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: 74021115, JOURNEY FEM OX NP BCS RT SZ 5, 08LM08552; 74022216, JOURNEY TIBIA BASE NP RT SZ 6, 09FM13405; 74024832, JRNY BCS PAT RSF RD 32 MM STD, 09FM03914
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR