MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II NON-POR TIB SZ 7 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420190
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a fluoroscopically guided right tka aspiration was performed due to pain.
Additional Manufacturer Narrative
A review of the complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Our clinical/medical team concluded: conclusion: results from the arthrocentesis revealed a crp level of 10.00mg/l all other labs where within normal limits.There was no indication of any medical interventions provided to address the elevated crp.The x rays provided taken years after the elevated crp provided had the suspicion of the loosening of the tibial or femoral components of right tka.Details regarding the patient¿s weight bearing status, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported pain cannot be determined.However, the loosening of the components could have been a contributing factor to the reported the pain.Although a fluoroscopically guided right tka aspiration was performed two months post revision no result were provided for review.Therefore, were are unable to confirm an infection as a contributory factor.The patient impact beyond the reported pain cannot be determined.Without the actual products involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.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.(b)(6) and/or (b)(6), 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.) conclusion: (b)(6): results from the arthrocentesis revealed a crp level of 10.00mg/l all other labs where within normal limits.There was no indication of any medical interventions provided to address the elevated crp.(b)(6): the x-rays provided taken years after the elevated crp provided had the suspicion of the loosening of the tibial or femoral components of right tka.Details regarding the patient¿s weight-bearing status, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the limited information provided and without the return of the device for evaluation the root cause of the reported pain cannot be determined.However, the loosening of the components could have been a contributing factor to the reported the pain.(b)(6): although a fluoroscopically guided right tka aspiration was performed two months post revision no result were provided for review.Therefore, were are unable to confirm an infection as a contributory factor.The patient impact beyond the reported pain cannot be determined.No further clinical assessment is warranted at this time.Approved by (b)(6), md on (b)(6) 19.

• Brand Name: GNS II NON-POR TIB SZ 7 RIGHT
• 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: 8350703
• Report Number: 1020279-2019-00690
• Device Sequence Number: 13888241
• Product Code: JWH
• UDI-Device Identifier: 03596010206374
• UDI-Public: 03596010206374
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2019

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: 07/05/2024
• Device Catalogue Number: 71420190
• Device Lot Number: 14GM04072
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 06/16/2019
• 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: 55 YR