MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT13; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74023264
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, after surgery had been performed, the patient experienced a systemic infection where his knee aspirate had a white count of 160k.This adverse event was solved by a revision surgery on (b)(6) 2022 the poly was removed and found to have a broken post a new poly was inserted.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A visual inspection of the images provided revealed that the device shows signs of significant wear, scratches and gouges.The clinical/medical investigation concluded that, this case reports that although the patient was scheduled for a knee revision at another facility, a poly-revision was performed ¿beforehand because of systemic infection¿ and the poly was found to be broken and was exchanged.Of note, it was reported that the patient was also being treated for a gangrenous gallbladder and the patient¿s knee aspirate-wbc was 160k.It was communicated that no additional clinically relevant documentation/information was available.Two photos of the explanted poly were provided and although the poly appeared to be worn, the photos do not provide insight into the root cause of the events.Further root cause assessment cannot be performed based on the information provided.The patient impact beyond those which were reported cannot be determined as the patient¿s current health status is unknown.No further 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, but no similar events for the batch based on the historical data, 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.Also, acute post-surgical infection has been identified in possible adverse effects.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.A review of the sterilization records revealed the batch was sterilized within normal parameters.According with the inspection procedure, the final inspection includes the verification of part configuration per print.Also, per material specification, the quality and manufacture of ultra-high-molecular-weight polyethylene as ram-extruded gur 1050 rod and compression-molded gur 1020 rod and plate shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, size selected, postoperative care, loss of sterility during procedure, post-operative healing issue, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: JOURN ART INS BCS STD 5-6 LT13
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 13591706
• Report Number: 1020279-2022-00854
• Device Sequence Number: 17630015
• Product Code: JWH
• UDI-Device Identifier: 03596010555236
• UDI-Public: 03596010555236
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 08/28/2016
• Device Model Number: 74023264
• Device Catalogue Number: 74023264
• Device Lot Number: 06HM02744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/12/2023
• Date Device Manufactured: 08/31/2006
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male