MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POROUS TIBIAL TRAY SIZE 5-LEFT MEDIAL; PROSTHSISKNEFMROTBIALSMICONSTRANDUNCOMPRTMNTLUNCNDLARUNCMNTDPORUSCOATDMTALPOLYMR

Catalog Number	1-10012-500
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during uka surgery, the tibial anchor was implanted with the joint in extension, and the surgeon did not notice any gap between the tibial tray and the tibial bone surface, as they both appear to sit flush.When going to joint flexion, the porous tibial tray size 5-left medial pop up in the back, and a gap between the tibial tray and the tibial bone surface was evident.After this incident, the surgeon decided to remove the tibial anchor and a change in surgical technique was performed to switch to a cemented tibial tray.The patient's outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records 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 engage partial knee system revealed that the success of the operation depends on compliance with the operative technique supplied, and the proper use of the instrumentation supplied has been identified in the warnings and precautions.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: POROUS TIBIAL TRAY SIZE 5-LEFT MEDIAL
• Common Device Name: PROSTHSISKNEFMROTBIALSMICONSTRANDUNCOMPRTMNTLUNCNDLARUNCMNTDPORUSCOATDMTALPOLYMR
• 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: 14345779
• Report Number: 1020279-2022-02268
• Device Sequence Number: 11908943
• Product Code: NJD
• UDI-Device Identifier: 00885556873199
• UDI-Public: 885556873199
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: 01/05/2026
• Device Catalogue Number: 1-10012-500
• Device Lot Number: 101245
• 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: 04/10/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male