MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY PF IMPLANT MED LT; PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71461015
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after tka surgery was performed on an unknown date, the patient experienced unspecified complications that required a revision surgery on (b)(6) 2024.During this procedure, the journey pfj femoral component was found to be fractured off.Patient's outcome is unknown.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Event or Problem Description
It was reported that, after a left medial uka surgery was performed on (b)(6) 2017, the patient experienced increase in pain.X-rays were performed on (b)(6) 2023 and they were unremarkable.However, on (b)(6) 2023 x-rays revealed there was a visible fracture of the trochlea and a posterior rupture on the surface of the journey pf implant med lt.This event was addressed by performing a revision surgery on (b)(6) 2024, during which the fractured femoral component was removed.Patient's health status is good.Replacement operation went well.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device is fractured.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported pain, fracture of the trochlea and the posterior surface rupture cannot be determined.The patient's body mass index of 42, and metabolic syndrome as likely contributory factors to the reported pain and revision.It is unknown if the instructions for use for knee systems, was adhered to.According to the report, the revision surgery went well, and the patient is in good health.The patient impact is determined to be the revision.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for knee systems revealed that break of implant has been identified in warnings and precautions section as a result of strenuous activity or trauma.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of zirconium-2.5% niobium alloy wrought bar shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.Corrected data: d9 (item was discarded at the facility).
Event or Problem Description
It was reported that, after a right patellofemoral surgery was performed on (b)(6) 2017, the patient experienced increase in pain.X-rays were performed on (b)(6) 2023 and they were unremarkable.However, on (b)(6) 2023 x-rays revealed there was a visible fracture of the trochlea and a posterior rupture on the surface of the journey pf implant med rt.This event was addressed by performing a revision surgery on (b)(6) 2024, during which the fractured femoral component was removed.Patient's health status is good.Replacement operation went well.
Additional Manufacturer Narrative
H10- additional information.D10- concomitant medical products.G4- pma/510(k)number h11- corrected data.B5- describe event or problem.D1- brand name.D4- catalog number, lot number, expiration date, unique identifier (udi) #.H4- device manufacture date.

• Brand Name: JOURNEY PF IMPLANT MED LT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19057131
• Report Number: 1020279-2024-00691
• Device Sequence Number: 6272053
• Product Code: KRR
• UDI-Device Identifier: 03596010544223
• UDI-Public: 03596010544223
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/04/2024
• 2 Devices were Involved in the Event: 1 2

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: 04/09/2026
• Device Catalogue Number: 71461015
• Device Lot Number: 16DM07927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 06/05/2024; 06/28/2024
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 04/22/2024; 06/10/2024; 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GNS II BICONVEX PAT 26MM: 71420568,15GM15882
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Unknown