MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 7-8 10MM; PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY

Model Number	71453177
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision knee replacement for the knee that was ¿giving way¿ and subluxing patella.The surgeon exchanged the tibial insert to a thicker one and lateral release performed.The knee was assessed as clinically stable at the completion of the operation by the surgeon.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed on a left knee that was ¿giving way¿ and a subluxing patella.An exchange of tibial insert to a thicker one and a lateral release was performed.The affected legion high flexion insert, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.The surgeon opened the knee and found that the ¿quads repair¿ from primary knee replacement had failed.A medical analysis noted that three x-rays were provided but no medical documents or operative notes came.Without supporting clinical documents, a thorough medical assessment cannot be performed at this time.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to size of device or user/procedural variance.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 7-8 10MM
• Common Device Name: PROST, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9687642
• Report Number: 1020279-2020-00503
• Device Sequence Number: 361737
• Product Code: JWH
• UDI-Device Identifier: 00885556487143
• UDI-Public: 00885556487143
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2020

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 Model Number: 71453177
• Device Catalogue Number: 71453177
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 05/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention