MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN LEGION IMPLANT; PRSTHESSKNEEPTELLOFMROTBILSMICNSTRAINDCMNTEDPLYMRMTALPLYMR

Model Number	71443101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to anterior knee pain and instability.Insert was exchanged from a 11mm to a 15mm poly.Patella was resurfaced with 32mm implant.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that, per complaint details, the reason for revision was anterior knee pain, instability, and patellar component introduction (to resurface an unresurfaced patella).It was communicated that no clinically relevant documentation would be provided; therefore, a thorough medical investigation could not be performed.Patient impact beyond the reported pain, instability and revision/resurfacing could not be determined.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Pain is a complication that can be associated with any surgery.Some potential probable causes could include patient reaction or a post-operative healing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN LEGION IMPLANT
• Common Device Name: PRSTHESSKNEEPTELLOFMROTBILSMICNSTRAINDCMNTEDPLYMRMTALPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9658885
• Report Number: 1020279-2020-00439
• Device Sequence Number: 2756668
• Product Code: JWH
• UDI-Device Identifier: 03596010568243
• UDI-Public: 03596010568243
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2020

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 Model Number: 71443101
• Device Catalogue Number: 71443101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020; 04/14/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/04/2020; 04/17/2020
• 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