MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE PS INSERT SZ 7-8 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453257
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to implant fracture.Patient fainted and fell, breaking the post.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to implant fracture.Patient fainted and fell, breaking the post.The associated legion ps insert was returned and evaluated.A lab analysis conducted during this investigation indicated that the insert and insert post fragment were examined visually and using optical microscopy.No destructive testing was conducted.The analysis noted that on the returned insert component, some abrasion, discoloration and deformation were observed in the bearing regions on the superior surface.Scratches and wear patterns were observed on the inferior surface of the insert and some material damage could be seen around the periphery of the explant.Significant material deformation was present on the insert around the fracture surface.This fracture could have been caused due to repeated posterior impingement of the femoral cam on the post combined with excessive loads.However, based on the results of this investigation, this could not be isolated as the root cause for this particular failure mode.No material or manufacturing deviations were observed in the process of this investigation.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No medical documents were received for investigation, thus no medical assessment can be performed at this time.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: LGN XLPE PS INSERT SZ 7-8 9MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8610485
• Report Number: 1020279-2019-01936
• Device Sequence Number: 2220787
• Product Code: JWH
• UDI-Device Identifier: 00885556255803
• UDI-Public: 00885556255803
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: Health Professional
• Device Expiration Date: 12/03/2021
• Device Catalogue Number: 71453257
• Device Lot Number: 11CM12255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 121