MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXINIUM FEM SIZE 5 RIGHT; PRSTHSS,HP,SM-CNSTRND, MTL/CRMC/PLYMR,CEMENTEDORNON-POROUS,UNCEMENTED

Catalog Number 71420152

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

Patient Problems Injury (2348); Fibrosis (3167)

Event Date 04/23/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability, arthrofibrosis and excessive valgus angle.

Manufacturer Narrative

The affected genesis ii dished insert, genesis ii cmt tibial baseplate 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 without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported pain, arthrofibrosis, flexion instability, and excessive valgus angle cannot be confirmed and it cannot be concluded that the reported events were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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 5 RIGHT
• Type of Device: 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: 7921490
• MDR Text Key: 122148052
• Report Number: 1020279-2018-02038
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010430182
• UDI-Public: 03596010430182
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Catalogue Number: 71420152
• Device Lot Number: 13LM12815
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 03/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR