MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 3-4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453249
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during procedure, legion xlpe ps insert size 3-4 15mm did not lock into tibia.Procedure continued with a constrained insert, without a delay or and injury.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection on the returned insert shows very minor damage to the lock detail, which was probably from attempting to lock into the baseplate.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use document for this failure mode was conducted and concluded this failure mode has been identified.Our clinical/medical team noted: without the clinical information, a thorough medical investigation cannot be rendered.Based on the information provided, during the procedure the legion xlpe ps insert size 3-4 15mm wouldn¿t lock into tibia.As a result, the surgeon completed the procedure with a constrained insert, without a delay or patient injury.Therefore, no further clinical/medical assessment is warranted at this time.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.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 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 XLPE PS INSERT SZ 3-4 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11187810
• Report Number: 1020279-2021-00447
• Device Sequence Number: 3583285
• Product Code: JWH
• UDI-Device Identifier: 00885556255872
• UDI-Public: 00885556255872
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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 Expiration Date: 01/26/2025
• Device Model Number: 71453249
• Device Catalogue Number: 71453249
• Device Lot Number: 15AM19883
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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: Required Intervention