MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 7-8 LT11; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY

Model Number	74023283
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Joint Laxity (4526)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.Case: (b)(4).
Event or Problem Description
It was reported that, after a left tka surgery was performed on (b)(6) 2008, the patient reported sudden loss of stability during a tennis match.Furthermore, anamnestic examination indicated a possible fracture of the implant's post.This adverse event was treated by a revision surgery on (b)(6) 2022, in which the journ art ins bcs std 7-8 lt11 was exchanged.Intraoperatively, the post breakage of the articular insert was confirmed and significant polyethylene wear which had led to first signs of synovitis was also identified.Patient is currently in a healthy condition.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information: h7 (notification number added).Updated results of investigation: the associated device was returned and evaluated.The visual inspection revealed the post fractured off.The broken post was returned.The visual also reveals scratches, burrs and discoloration on the insert.The device shows signs of wear.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported ¿loss of stability,¿ synovitis and subsequent revision was reportedly due to the fractured post insert.The patient impact beyond the reported symptoms and revision cannot be determined.However, in reference to the patient¿s current health status, it has been communicated the ¿patient is in a healthy condition.¿ therefore, no further clinical/medical assessment can be rendered at this time.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 revealed similar events for the listed device over the previous 12 months however, no commonalities that would suggest a device deficiency was found nor an adverse trend.No similar events for the batch based on the historical data were found, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.A review of the risk management file revealed this failure mode was previously identified.In addition, a historical review concluded that this event was previously identified.The following actions were recommended: inform surgeons of the higher expected risk of revision for patients in whom the journey bcs was implanted and ensure clear communication that the device should only be used for polyethylene exchange revision of journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.According with inspection procedure, the final inspection includes the verification of part configuration per print.Also, material specification shall control the quality and manufacture of ultra-high-molecular-weight polyethylene.At this time, we have no reason to suspect 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.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the associated device was returned and evaluated.The visual inspection revealed the post fractured off.The broken post was returned.The visual also reveals scratches, burrs and discoloration on the insert.The device shows signs of wear.The knee insert post deformation and/or fracture may have been due to repeated posterior contact of the femoral cam on the post combined with excessive posterior to anterior shear force during activity.However, this could not be isolated as the root cause for this particular failure mode.Some additional factors that could have contributed to the reported event include patient anatomy, abnormal loading of limb and/or traumatic injury.The clinical/medical investigation concluded that, based on the information provided, the clinical root cause of the reported ¿loss of stability,¿ synovitis and subsequent revision was reportedly due to the fractured post insert.The patient impact beyond the reported symptoms and revision cannot be determined.However, in reference to the patient¿s current health status, it has been communicated the ¿patient is in a healthy condition.¿ therefore, no further clinical/medical assessment can be rendered at this time.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 revealed similar events for the listed device over the previous 12 months however, no commonalities that would suggest a device deficiency was found nor an adverse trend.No similar events for the batch based on the historical data were found, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for knee systems revealed in warnings and precautions that the implant can break or become damaged as a result of strenuous activity or trauma.The patient should be warned that the device does not replace normal healthy bone.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, material specification shall control the quality and manufacture of ultra-high-molecular-weight polyethylene.At this time, we have no reason to suspect 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: b2 (outcomes attributes to adverse event), d9, h3 (device returned to manufacturer), e1 (first name updated), h6 (health effect - clinical code).

• Brand Name: JOURN ART INS BCS STD 7-8 LT11
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN, CEMENT, POLY/MET/POLY
• 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: 16187768
• Report Number: 1020279-2023-00118
• Device Sequence Number: 6184924
• Product Code: JWH
• UDI-Device Identifier: 03596010555366
• UDI-Public: 03596010555366
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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: 03/28/2017
• Device Model Number: 74023283
• Device Catalogue Number: 74023283
• Device Lot Number: 07CM22293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 06/13/2023; 07/05/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 06/13/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• 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: 74021228/JOUR FEM COCR NP LT SZ 8; 74022228/JOURNEY TIBIA BASE NP LT SZ 8; 74024835/JRNY BCS PAT RESRF RD 35 MM STD
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male