MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAINED FEM 5 LT; PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY

Catalog Number	71421165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during revision, the device would not sit properly when screwed down.Delay of less than 30min reported.No injury or back up reported.
Additional Manufacturer Narrative
While reviewing the available information received by the manufacturer it was identified that this event should be re-evaluated for mdr reporting.The information received states that a device malfunctioned during a revision surgery but there is no confirmation that is was from smith and nephew components, 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: LGN OX CONSTRAINED FEM 5 LT
• Common Device Name: PROSTHESIS KNEE PATELLOFEMOROTIBIAL SEMI-CONSTRAINED CEMENTED POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8098916
• Report Number: 1020279-2018-02556
• Device Sequence Number: 18893287
• Product Code: JWH
• UDI-Device Identifier: 03596010543844
• UDI-Public: 03596010543844
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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 Catalogue Number: 71421165
• Device Lot Number: 18GM05412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 09/24/2019
• 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