MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM TIBIAL BASE PLATE SZ 3 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71422843
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tka surgery, the anthem tibial base plate sz 3 rt could not lock into the articular.It was changed the articular two times but still faced the same issue.The anthem tibial base plate sz 3 rt was already inserted into patient and could not take it out.It was tried everything but still could not lock articular completely so this event could caused revision in the future.The procedure was resumed, without any delay, using the same device.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that during a tka surgery, the surgeon attempted to place two sizes for the tibial insert (size 13 and size 15) into the anthem tibial base plate sz 3 rt but the inserts would not lock.Since the anthem tibial base plate sz 3 rt was already inserted into patient, it could not be taken out.It was tried everything but the surgeon still could not lock the tibial insert completely so this event could caused revision in the future.The procedure was resumed, without any delay, using the tibial insert size 15.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
B5: event description: h3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.The image provided is a photo of the outer packaging of the articular insert therefore a visual inspection of the image provided could not reveal any defects that would prevent the device from working/functioning as intended.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 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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.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.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the tibial baseplate was not returned for evaluation.The 13mm sz 3-4 insert was returned and evaluated.A visual inspection of the returned device reveals scratches and gouges in the surface of the device.The visual also reveals the device has damage along the base, more than likely from attempted insertion.This inspection was conducted using a magnifying glass.Based on the information provided, the unsatisfactory experience could be confirmed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional evaluation performed on the insert revealed that the device has damage that appears to be from attempted use and has the potential to cause an event during attempted mating to the tibial base as described in the complaint.The damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.For the baseplate, 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.For the insert, a review of complaint history revealed a similar event 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 risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.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: ANTHEM TIBIAL BASE PLATE SZ 3 RT
• 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: 19499217
• Report Number: 1020279-2024-01097
• Device Sequence Number: 6661200
• Product Code: JWH
• UDI-Device Identifier: 00885556531464
• UDI-Public: 00885556531464
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K142807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71422843
• Device Lot Number: 23GB01404
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 08/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/04/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male