MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	71453213
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/23/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a knee revision was performed due to a broken post due to a fall.The exact same component was replaced due to her history.There was no need for further constraint.All other components appeared to be in good condition.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
E1: information was corrected.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed and the failure mode was confirmed, the post broke off the implant.The clinical/medical investigation concluded that, this complaint reports a broken insert post, secondary to a fall.The patient was reportedly happy with her knee prior to accident.The exact same component was replaced due to her history.There was no need for further constraint.All other components appeared to be in good condition.: smith and nephew has not received adequate materials (the operative report) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique or implant failure.Based on this investigation, the need for corrective action is not indicated.Should the device or 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 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10160121
• Report Number: 1020279-2020-02428
• Device Sequence Number: 2823668
• Product Code: JWH
• UDI-Device Identifier: 00885556034941
• UDI-Public: 00885556034941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2021

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: 10/10/2019
• Device Model Number: 71453213
• Device Catalogue Number: 71453213
• Device Lot Number: 09KM06247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2020
• Supplement Date Received by Manufacturer: 05/23/2020; 06/28/2021
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/18/2020; 06/29/2021
• 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