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	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the journey i bcs component jump the post years ago, after implantation.Therefore, the surgeon relocated the knee.According to the surgeon after the procedure, the patient was doing fine.Subsequently, the patient jumped the post again 3-4 weeks ago, so the surgeon opening the knee and it was found the tip of the post has broken off.Consequently, the poly and broken pieces were removed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.The lab analysis concluded that the returned component was examined visually.No destructive analysis was performed.Scratches and burnishing were observed on the articular and distal surfaces of the tibial insert.The post of insert was fractured and experienced damage, deformation, and burnishing.No material or manufacturing deviations were discovered in this investigation.The clinical/medical evaluation concluded that per complaint details, a patient who had a prior dislocated knee with relocation (at some point after the primary journey i bcs in 2007), recently ¿jumped the post again¿ and the tip of the post was found broken off.Per correspondence, no further information is available for the dislocation/relocation that was performed years ago.The requested operative notes and x-rays were not provided for inclusion in the medical investigation, therefore, the definitive root cause of the event could not be fully assessed.The patient impact beyond the reported fractured tip of the post and revision could not be determined.No further medical assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be re-opened for further evaluation.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should 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.We consider this investigation closed.

• 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: 10686437
• Report Number: 1020279-2020-05436
• Device Sequence Number: 3124092
• Product Code: JWH
• UDI-Device Identifier: 03596010555137
• UDI-Public: 03596010555137
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2016
• Device Model Number: 74023251
• Device Catalogue Number: 74023251
• Device Lot Number: 06JM01604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 08/12/2021
• 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