MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 4 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421364
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with a lateral condyle fracture that was treated with a surgical procedure.The event is already resolved.
Additional Manufacturer Narrative
The associated legion femoral assembly was not returned for evaluation.The device was manufactured in 2016.Our investigation including a review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.The batch number was provided for the device.Thus, a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our clinical evaluation noted that no clinical information or the explant was provided.However, the x-rays provided confirm the fracture and fixation, in addition to the emailed surgeon¿s statement this adverse event was the complication of the surgical technique and not the fault of the smith and nephew¿s device.The event has been reported as resolved.Therefore, no further clinical/medical assessment is warranted at this time.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew, or its employees caused or contributed to the potential event described in this report.

• Brand Name: LGN HK FEM ASSEMBLY SZ 4 RT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8002262
• Report Number: 1020279-2018-02261
• Device Sequence Number: 19130198
• Product Code: KRO
• UDI-Device Identifier: 00885556414941
• UDI-Public: 00885556414941
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2019

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: 71421364
• Device Lot Number: 16CM02108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 10/01/2018; 10/01/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 02/05/2019; 04/03/2019
• 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: 71101044/15DM18335; 71421385/15GTM0014S; 71421385/UNK LOT; 71421902/15GBP0050A; 71421902/UNK LOT; 71422157/13CAP7276B; 71422157/UNK LOT; 71423342/13KM08087A; 71423342/UNK LOT; 71424202/14HAP6594A; 71424202/14HSM0209A; 71424202/UNK LOT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 65