MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OFFSET COUPLER 2MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71424223
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.All parts were removed and replaced with cement moulds from heraeus.No more information available.
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.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 OFFSET COUPLER 2MM
• 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: 9078324
• Report Number: 1020279-2019-03403
• Device Sequence Number: 14072910
• Product Code: JWH
• UDI-Device Identifier: 03596010547125
• UDI-Public: 03596010547125
• Combination Product (Y/N): N
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71424223
• Device Lot Number: 18ASM0046A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1