MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN GENESIS II TOTAL KNEE IMPL; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported in the publication "hinged device for fractures involving the proximal interphalangeal joint".Authors: g.Li, md, orthopaedic surgeon, department of orthopaedic surgery, tongji university, shanghai tenth people¿s hospital, zhabei qu, shanghai 200085, china, that 200 patients underwent a tka procedure (standard procedure involving a posterior cruciate-substituting cemented prosthesis genesis ii oxinium (smith &nephew inc., memphis, tn).A patient presented deep vein thrombosis (dvt) and were treated with rivaroxaban (15mg twice a day for 21 days and then 20 mg daily).Those with a distal dvt were not treated with anticoagulants on the advice of a hematologist.

Manufacturer Narrative

H3, h6: the device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in this literature review article indicates that 33 patients presented deep vein thrombosis (dvt) and were treated with rivaroxaban.Those with a distal dvt were not treated with anticoagulants on the advice of a hematologist.Per the complaint, no relevant clinical information will be provided.Therefore, without clinically relevant patient-specific supporting documentation a thorough medical investigation cannot be performed, and the patient outcome beyond that which is documented in the article cannot be confirmed.Therefore, no further clinical assessment is warranted at this time.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN GENESIS II TOTAL KNEE IMPL
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10752524
• MDR Text Key: 213619997
• Report Number: 1020279-2020-05916
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN; UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN; UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN; UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN; UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN; UNKNOWN GENESIS II TOTAL KNEE IMPL: UNKNOWN
• Patient Outcome(s): Required Intervention