MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CON ART INS 9MM SZ 3-4; PRSTHSSKNEPATLLOFMROTBLSMICNSTRNDCMNTDPLYMR/MTAL/PLYMR

Catalog Number	71420523
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that legion constrained inserts were a mixture of some labelled genesis constrained and some labelled legion constrained within a run of sizes.Traditionally the gii constrained liners are only for use with legion (built in rotation affects congruency with post), but having them labelled as gii is causing some strong challenges from surgeons who insist they can use them with gii ps femurs (¿they say genesis so can use with genesis¿).
Additional Manufacturer Narrative
This event should be re-evaluated for mdr reporting.The information states that until now there is no confirmation that the devices reported were used on any patient, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: LEGION CON ART INS 9MM SZ 3-4
• Common Device Name: PRSTHSSKNEPATLLOFMROTBLSMICNSTRNDCMNTDPLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9580367
• Report Number: 1020279-2020-00228
• Device Sequence Number: 16277355
• Product Code: JWH
• UDI-Device Identifier: 03596010555823
• UDI-Public: 03596010555823
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71420523
• Device Lot Number: 18ET03135
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1