MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CONST INSRT W/JRNY LOCK SZ 3-4 11MM; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	13HM17062
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/20/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to medial femoral condyle metaphyseal compression fracture consistent with knee pain and difficulty walking.
Additional Manufacturer Narrative
Corrections.
Additional Manufacturer Narrative
Following receipt of additional information concerning this case it has been determined that the initial report was submitted in error.Please therefore disregard this report.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: GII CONST INSRT W/JRNY LOCK SZ 3-4 11MM
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7149005
• Report Number: 1020279-2017-01348
• Device Sequence Number: 11072181
• Product Code: JWH
• UDI-Device Identifier: 00885556083932
• UDI-Public: 00885556083932
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2018

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: 08/21/2023
• Device Catalogue Number: 13HM17062
• Device Lot Number: 10FM03225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 12/14/2017; 12/14/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 02/26/2018; 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022224/14HM06433; 74024838/13LM10928
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR