MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 4 LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	71420106
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the femur and stemmed were revised, poor bone stock + osteoporosis + oxinium metal allergy.Bone from anterior femur fell out after trialling.Implants well fixed orientation acceptable.No more information provided yet.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that the x-rays provided were reviewed but do not contribute.Without the requested clinical information, lab values, operative reports, or the explant the root cause of the broken component cannot be determined.However, we cannot rule out the patient¿s age, weight, mental status, bone quality, osteoporosis, fall history, weight bearing prior to full bone union as contributing factors.The future impact to the patient beyond the revision cannot be determined.No further clinical/metal assessment is warranted at this time.Without the actual devices involved our investigation cannot proceed.

• Brand Name: GNS II CMT TIB SIZE 4 LEFT
• 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: 8904434
• Report Number: 1020279-2019-03083
• Device Sequence Number: 286028
• Product Code: JWH
• UDI-Device Identifier: 03596010206268
• UDI-Public: 03596010206268
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• 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): 11/19/2019

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 Model Number: 71420106
• Device Catalogue Number: 71420166
• Device Lot Number: 15KM10933
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 11/12/2019
• Initial Report FDA Received Date: 08/18/2019
• Supplement Report FDA Received Date: 11/18/2019; 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention