MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453221
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); Joint Dislocation (2374)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery performed on (b)(6) 2023, the patient complained of weakness when straightening the leg, and it was noticed that the lgn ps high flex xlpe sz 5-6 9mm had slipped forward.So a revision surgery was performed on (b)(6) 2023, where the 5-6 9mm was replaced by a 5/6-11 xlpe insert.When the lgn ps high flex xlpe sz 5-6 9mm was taken out, a piece of the insert groove was missing, but no residue was found in the patient's body.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed a piece of the insert groove is missing.The visual also reveals scratches, gouges and discoloration in the surface of the device.The device shows signs of wear.The clinical/medical investigation concluded that, based on the available information with an early revision at 3½ weeks, the ¿sense of weakness when straightening¿ the knee and reported ¿insert slipped forward¿, it cannot be confirmed that the initial size 5-6, 9mm thick insert was successfully locked into the tibial baseplate.Additionally, the replacement with a thicker, 11mm insert suggests joint laxity after the primary implantation; however, this cannot be definitively concluded.Reportedly ¿no residue was found in the patient's body¿ upon removal of the primary insert and the missing piece of the insert groove was not recovered; therefore, it is unknown if the piece of xlpe was retained.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 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 improper fixation, and/or migration of the components could cause possible adverse effects.Also, the warnings and precautions section establish that the implant can become damaged as a result of strenuous activity or trauma.The patient should be warned of surgical risks, and made aware of 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.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 abnormal loading of limb, alignment, size selected, patient anatomy, procedural/user error and/or traumatic injury.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: LGN PS HIGH FLEX XLPE SZ 5-6 9MM
• 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: 16970550
• Report Number: 1020279-2023-01087
• Device Sequence Number: 20196957
• Product Code: JWH
• UDI-Device Identifier: 00885556035337
• UDI-Public: 00885556035337
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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 Model Number: 71453221
• Device Catalogue Number: 71453221
• Device Lot Number: 21FM24168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/20/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: Required Intervention
• Patient Sex: Female