MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 1-2 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	71453202
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to instability of knee.A part of insert which removed lacked so the surgeon wants to know the reason why it was lacked.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement.The features that could be measured were within specification.A lab analysis indicated that the burnishing on the inferior surface of the insert was 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 anterior locking detail could be caused if the insert was not fully seated posteriorly, which can lead to incomplete fixation of the insert to the baseplate and could cause loosening or dissociation of the insert.The deformation on the posterior surface of the insert post was likely due to contact with the femoral cam during expected use in vivo.No manufacturing deviations were noted during this investigation.Based on the investigation conducted, the exact cause of the insert dissociation was not able to be determined.A clinical analysis indicated that based on the available information and the product analysis, the exact root cause of the insert disassociation/instability cannot be concluded.Should any relevant clinical/medical information become available for either (b)(4), this complaint can be re assessed.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A dimensional inspection was attempted; the damage/deformation at several features of the device would not allow for accurate measurement; features that could be measured were within specification.A lab analysis indicated that the burnishing on the inferior surface, likely caused by repeated motion between the insert and the tibial baseplate; could have been caused during or after the reported insert loosening.The deformation of the anterior locking detail could be caused if the insert was not fully seated posteriorly, leading to incomplete fixation of the insert to the baseplate and could cause loosening or dissociation of the insert.The deformation on the posterior surface of the insert post was likely due to contact with the femoral cam during expected use in vivo.No manufacturing deviations were noted during this investigation.Based on the investigation conducted, the exact cause of the insert dissociation was not able to be determined.A clinical analysis indicated that based on the available information and the product analysis, the exact root cause of the insert disassociation/instability cannot be concluded.The second revision to come has not been performed at this time.After the surgery has been completed and we receive notification, and medical documents, the complaint will be re-opened and assessed at that time.A review of complaint history on the listed part revealed no prior complaints for the listed batch.Based on this investigation, the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 1-2 11MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6993148
• Report Number: 1020279-2017-00952
• Device Sequence Number: 1496371
• Product Code: JWH
• UDI-Device Identifier: 00885556034316
• UDI-Public: 00885556034316
• Combination Product (Y/N): N
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2019

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: No Information
• Device Catalogue Number: 71453202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017; 10/18/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 05/10/2018; 02/21/2019
• 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