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

Model Number	71453214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.During surgery, was found that the post broke while inside the patient.The lgn ps high flex xlpe sz 3-4 15mm was swapped out.The patient outcome is normal.No foreign body was retained in patient.No additional information is available at this time.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device shows the product has deep cuts on the inferior surface and scratches on the articulating surface of the part.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical evaluation noted that revision surgery was performed due to dislocation.Per correspondence, the patient outcome was ¿normal¿ with no foreign body retained in the patient.No further patient impact would be anticipated based on the information provided.No further medical assessment is warranted at this time.Per the report, the post did not break.The patient damaged their later collateral ligament, therefore was dislocating.The doctor switched to a constrained insert to solve the problem.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.The root cause was noted that the patient damaged their later collateral ligament, therefore was dislocating.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 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: 11086717
• Report Number: 1020279-2020-07857
• Device Sequence Number: 3310988
• Product Code: JWH
• UDI-Device Identifier: 00885556035108
• UDI-Public: 00885556035108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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 Model Number: 71453214
• Device Catalogue Number: 71453214
• Device Lot Number: 19KM02728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 05/27/2021
• 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: Hospitalization; Required Intervention