MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453212
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Event or Problem Description
It was reported that, after a tka surgery done 12 years ago, patient underwent a revision surgery on (b)(6) 2023 due to unclear circumstances.During this revision, a gii ps hi flex isrt sz 3-4 9 was explanted.For the insert replacement, a lgn ps high flex xlpe sz 3-4 11mm was unable to be locked.The lgn ps high flex xlpe sz 3-4 11mm was removed, the rail on the tray and insert were inspected, then it was unable to be inserted.A ttt procedure was performed for full access to the side of the tray, and finally, the lgn ps high flex xlpe sz 3-4 11mm was used with a small amount of "depuy cmw2" cement at the front of the tray to lock the replacement insert.All the inserts and the tibial tray had been checked for defects multiple times and none were found.A delay of approximately 1 hour to the surgery was reported.No other complications were reported.
Additional Manufacturer Narrative
Given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, the intra-operative issue with locking of the insert was resolved with a change in the surgical technique by the surgeon use of a lgn ps high flex xlpe sz 3-4 11mm with a small amount of "depuy cmw2" cement in the front of the tray to lock the replacement insert.It was reported the procedure completed with a back-up; however, the current health status of the patient is unknown.Therefore, the patient impact beyond the reported one-hour surgical delay and insert wear and the modified surgical with a change to a to competitor cement cannot be determined.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 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 surgical technique used, size selected or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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: LGN PS HIGH FLEX XLPE SZ 3-4 11MM
• 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: 17114129
• Report Number: 1020279-2023-01288
• Device Sequence Number: 18000755
• Product Code: JWH
• UDI-Device Identifier: 00885556034170
• UDI-Public: 00885556034170
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 07/27/2023

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 Model Number: 71453212
• Device Catalogue Number: 71453212
• Device Lot Number: 23AM10413
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/27/2023
• Date Device Manufactured: 01/18/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown