MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 5-6 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	OR71453223
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to broken post.New insert was put in place.
Additional Manufacturer Narrative
The associated legion ps high flexion articular insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the articulating and non-articulating surfaces of the device show evidence of wear.There are small slits on the anterior periphery of the insert.The insertion/extraction slot is deformed, likely due to removal.The post is deformed and fractured.There were no observations of material or manufacturing deviations in the course of this investigation.A clinical evaluation noted that there is an insufficient clinical relevant documentation provided, therefore a thorough medical investigation could not be performed to assess the cause of the revision 5.5 years post implantation.The patient impact beyond probable clinical symptoms, the revision procedure and an expected post-operative rehabilitative phase cannot be determined.No further medical assessment is warranted at this time.A review of manufacturing records for the listed batch did not reveal any deviations that could have contributed to this issue.A review of complaint history on the listed part revealed no prior complaints for this failure mode with the same batch number.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 5-6 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8069427
• Report Number: 1020279-2018-02475
• Device Sequence Number: 2154526
• Product Code: JWH
• UDI-Device Identifier: 00885556033425
• UDI-Public: 00885556033425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: Health Professional
• Device Expiration Date: 01/11/2021
• Device Catalogue Number: OR71453223
• Device Lot Number: 11AM07116
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 03/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 108