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	Unintended Movement (3026)
Health Effect - Clinical Codes	Injury (2348); Fibrosis (3167)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to asceptic loosening and arthrofibrosis.
Additional 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.¿.
Additional 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
• 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: 7921374
• Report Number: 1020279-2018-01880
• Device Sequence Number: 13864199
• Product Code: LZO
• UDI-Device Identifier: 03596010430175
• UDI-Public: 03596010430175
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2025
• Device Catalogue Number: 71420150
• Device Lot Number: 15DM14000
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 02/28/2019; 02/28/2019
• Initial Report FDA Received Date: 09/30/2018
• Supplement Report FDA Received Date: 03/03/2019; 10/15/2019
• 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
• Patient Age: 58 YR