MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 4 RIGHT; PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED

Catalog Number	71420150
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Radiation Exposure, Unintended (3164)
Date of Event	02/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that doctor sent esr and crp exams, patient has taken percocet for pain management, x-rays were performed, a cortisone injection and a manipulation under anesthesia process were done.
Additional Manufacturer Narrative
The affected genesis ii dished insert, genesis ii cmt tibial baseplate, genesis ii biconvex patellar component and genesis ii oxinium femoral component were not returned for evaluation.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode.A clinical evaluation noted that the provided metal ltt report indicated a positive, highly reactive to nickel and mildly reactive to zirconium, iron, & cobalt.The initial implanted oxinium devices contain less than 0.0035% nickel content.Details regarding the patient¿s weight-bearing status, medical history, bone quality, and other additional clinical relevant information have not been provided.Although it was reported that x-rays were performed along with injections and an mua, no x-rays or reports were provided.Based on the limited information provided and without the return of the devices for evaluation, the root cause of the reported for joint instability and pain cannot be determined.It can¿t be concluded if the reported pain and inflammation are related to the patient¿s reactions but these would not be not failures of the devices.No further clinical assessment is warranted at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.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.

• Brand Name: GII OXINIUM FEM SIZE 4 RIGHT
• Common Device Name: PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7931910
• Report Number: 1020279-2018-02057
• Device Sequence Number: 1914609
• Product Code: LZO
• UDI-Device Identifier: 03596010430175
• UDI-Public: 03596010430175
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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 Expiration Date: 11/16/2023
• Device Catalogue Number: 71420150
• Device Lot Number: 13LM12815
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 03/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR