MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 5-6 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71453123

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

Complaint reference number: (b)(4).

Event Description

It was reported that when the lgn cr high flex xlpe sz 5-6 13mm was opened, dr krenzel inspected the poly and noticed some pitting and imperfections in the articulating surface on the posterior portion near the posterior lip and did not want to use it.The procedure was resumed, without any delay, using a s+n backup device.The patient was not injured as a consequence of this problem.

Manufacturer Narrative

The associated device was returned and evaluated.A review made by the quality engineering team revealed that a visual inspection could not confirm the stated failure mode.This visual inspection was performed per visual standard procedure and found the device to be acceptable.In addition, a surface finish inspection was performed on the articular surface per work instruction, and was found to be within acceptable limits.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.A visual inspection of the returned device reveals some scratches and gouges in the surface of the device.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.According to the drawing print, it verifies to break all sharp edges and all raii must blend.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.For this reason, along with the high detectability of the defect in manufacturing, and lack of additional complaints for this batch, no more investigation is required.No defects were found on the returned device, therefore no factors that can contribute the reported event can be delineated.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 CR HIGH FLEX XLPE SZ 5-6 13MM
• Type of Device: 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: 16975976
• MDR Text Key: 315785791
• Report Number: 1020279-2023-01091
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556035344
• UDI-Public: 00885556035344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71453123
• Device Catalogue Number: 71453123
• Device Lot Number: 22GM13181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1