MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CR HIGH FLEX XLPE SZ 1-2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71453103
Medical Device Problem Codes	Flaked (1246); Scratched Material (3020)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Implant Pain (4561)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tka surgery had been performed, the patient fell and started experiencing pain.It was discovered that legion cr high flex xlpe size 1-2 13mm was chipped so a revision surgery was performed to replace it.The patient outcome is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device is heavily worn with chips out of the material on one side of the articular surface.The clinical/ medical investigation concluded that, per the complaint details, 6 months following a fall, the patient reported knee pain.A revision surgery was performed due to a chipped poly insert.To date, the requested x-rays and surgical report shave not been provided.The patient's fall cannot be ruled out as a possible contributing factor.The patient impact beyond the reported revision cannot be determined.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality 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 review of the risk management file and instructions for use documents revealed this failure mode was previously identified.The probable cause for this event is likely a traumatic injury.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 1-2 13MM
• 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: 10292504
• Report Number: 1020279-2020-03312
• Device Sequence Number: 13654196
• Product Code: JWH
• UDI-Device Identifier: 00885556034149
• UDI-Public: 00885556034149
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 05/14/2018
• Device Model Number: 71453103
• Device Catalogue Number: 71453103
• Device Lot Number: 08EM12791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 05/28/2021
• 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
• Patient Age: 56 YR