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

Device Problem Unintended Movement (3026)

Patient Problems Injury (2348); Fibrosis (3167)

Event Date 05/15/2018

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to asceptic loosening and arthrofibrosis.

Manufacturer Narrative

The affected genesis ii oxinium femoral component and genesis ii cemented tibial baseplate were not returned for evaluation.A clinical evaluation noted that based on the documents provided and reviewed, arthrofibrosis and aseptic loosening of the tibial baseplate is the root cause of the revision.The root cause of the patient¿s continued post revision right foot issues cannot be determined; however it was noted by the surgeon that ¿it is really rare to have a tibial nerve issue in the plantar aspect of the foot from a knee replacement.¿ our investigation included a review of the manufacturing records for the listed batch 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 with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive at this time.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) narrative in excess of 2000 characters; please see attached mi report.Approved by legal & j.Templeton, medical director in conclusion: based on the documents provided and reviewed, arthrofibrosis and aseptic loosening of the tibial baseplate is the root cause of the revision.The root cause of the patient¿s continued post-revision right foot issues cannot be determined; however it was noted by the surgeon that ¿it is really rare to have a tibial nerve issue in the plantar aspect of the foot from a knee replacement.¿.

Manufacturer Narrative

The associated complaint devices were not returned.The clinical/medical team concluded, based on the documents provided and reviewed, arthrofibrosis and aseptic loosening of the tibial baseplate is the root cause of the revision.The root cause of the patient¿s continued post-revision right foot issues cannot be determined; however it was noted by the surgeon that ¿it is really rare to have a tibial nerve issue in the plantar aspect of the foot from a knee replacement.¿ 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/failure mode.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: GII OXINIUM FEM SIZE 4 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: 7921374
• MDR Text Key: 122148044
• Report Number: 1020279-2018-01880
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010430175
• UDI-Public: 03596010430175
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2019

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 Catalogue Number: 71420150
• Device Lot Number: 15DM14000
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/30/2018
• Supplement Dates Manufacturer Received: 02/28/2019; 02/28/2019
• Supplement Dates FDA Received: 03/03/2019; 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR