MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE IMPLANT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed in 2017 due to femoral component loosening.Femoral component was exchanged.An additional revision surgery was performed on 2019 due to femoral loosening.Legion system explanted.
Additional Manufacturer Narrative
The associated complaint devices were not made available for evaluation.Therefore a product inspection could not be performed.After repeated requests, smith and nephew has been unable to obtain device details or confirm the alleged deficiency with the devices.Smith and nephew has an outstanding request with the reporter for information.As device details were not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the implanted device failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical assessment can be rendered at this time as no requested supporting documents were received.Without the return of the actual product involved and no product information available, our investigation of this report is inconclusive.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.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: KNEE IMPLANT
• 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: 8475273
• Report Number: 1020279-2019-01329
• Device Sequence Number: 19235573
• Product Code: JWH
• UDI-Device Identifier: 00885556108338
• UDI-Public: 00885556108338
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 08/11/2019
• 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