MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	71453174
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to the poly dislodged.
Additional Manufacturer Narrative
The associated device was returned for evaluation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.An evaluation by our research department determined that the burnishing and scratches on the inferior surface of the insert were likely caused by repeated motion between the insert and the tibial baseplate, and could have been caused during or after the reported insert loosening.The deformation of the posterior locking detail could be caused by having the insert sitting on top of the posterior locking region after disassociation.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 on the listed part revealed no additional complaints for the listed batch.Based on the investigation conducted, the exact cause of the insert dissociation was not able to be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information is received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7332813
• Report Number: 1020279-2018-00306
• Device Sequence Number: 902187
• Product Code: JWH
• UDI-Device Identifier: 00885556486993
• UDI-Public: 00885556486993
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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 Expiration Date: 10/02/2025
• Device Catalogue Number: 71453174
• Device Lot Number: 15KM02572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention