MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN HK FEM ASSEMBLY SZ 7 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71421367
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Legion hinge study; id: (b)(6); subject: (b)(6): intertrochanteric left hip fracture.It was reported that patient had an intertrochanteric left hip fracture resolved in surgical procedure.The surgeon claims the hinge system tends to buckle which may have caused the fall and the femoral fracture.Buckling is further attributed to lack of quadriceps muscle strength due to lack of appropriate post-operative recovery regiment.Also, it was stated by the doctor that s&n hinge knee system is noted as functioning well and remains implanted.
Additional Manufacturer Narrative
Additional information:concomitant medical products.Correction: event.
Event or Problem Description
It was reported that patient had an intertrochanteric left hip fracture resolved in surgical procedure.The surgeon claims the hinge system tends to buckle which may have caused the fall and the femoral fracture.Buckling is further attributed to lack of quadriceps muscle strength due to lack of appropriate post-operative recovery regiment.Also, it was stated by the doctor that s&n hinge knee system is noted as functioning well and remains implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: LGN HK FEM ASSEMBLY SZ 7 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: 8237914
• Report Number: 1020279-2019-00123
• Device Sequence Number: 16580721
• Product Code: KRO
• UDI-Device Identifier: 00885556414927
• UDI-Public: 00885556414927
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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: 71421367
• Device Lot Number: 15KM09234
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 12/19/2018; 12/19/2018
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/15/2019; 06/06/2019
• 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: 71422167 / 13EAP5419H; 71422167 / 13EAP5419H; 71424055 / 15HSM0162A; 71424225 / 16BSM0284J
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention