MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ8 RT; PRSTHSIS, KNEE, PTELLOFMROTIBIAL, SMI-CNSTRAIND, CMNTD, PLYMR/MTL/PLYMR

Model Number	71421208
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the surgeon states that the post wedge would not screw tight enough on the femur.The surgeon had to cement wedge into place.No delay to procedure, no injury to patient.S&n backup was available but not used.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.After a re-evaluation of the complaint, it was determined that no injury to the patient has been confirmed, therefore, 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 PS OXIN FEM SZ8 RT
• Common Device Name: PRSTHSIS, KNEE, PTELLOFMROTIBIAL, SMI-CNSTRAIND, CMNTD, PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9632602
• Report Number: 1020279-2020-00384
• Device Sequence Number: 14238299
• Product Code: JWH
• UDI-Device Identifier: 00885556029701
• UDI-Public: 00885556029701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: No Information
• Device Model Number: 71421208
• Device Catalogue Number: 71421208
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1