MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CMT TIB SIZE 5 RIGHT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71420186
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	09/17/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a silent stroke and was admitted to the hospital.She suffered of pain, swelling and discomfort for some weeks.She had various testing and procedures since that, and she requested something for pain control.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, (b)(4): based on the limited information provided and without the return of the device for analysis the root cause of the reported pain, instability, patellar mal tracking, and lateral patellar subluxation cannot be determined.(b)(4).No relevant clinical medical information was provided to conduct a thorough medical assessment.(b)(4): based on the information provided the cortisone injection was give as an efficient analgesic for the treatment of the patients rheumatoid arthritis and not due to mal performance of the smith and nephew device.The patient impact beyond the treatment cannot be concluded.No further medical assessment can be rendered at this time.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.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GNS II CMT TIB SIZE 5 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: 8348292
• Report Number: 1020279-2019-00637
• Device Sequence Number: 11289120
• Product Code: JWH
• UDI-Device Identifier: 03596010206350
• UDI-Public: 03596010206350
• 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): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71420186
• Device Lot Number: 13KM14575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR