MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,CEMNTD,POLYMR/METAL

Catalog Number	71421206
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented aseptic loosening and pain on his right knee several years after tkr.Knee prosthesis was removed on revision surgery and antibiotic beads were implanted.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.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: based on the information available, it is unknown if the osteolysis led to the loosening or the loosening and inflammation led to the osteolysis therefore the root cause of the ¿aseptic loosening¿ and osteolysis is unknown.Based on the cultures, white count, sed rate and crp it is not believed to be infection.Only the operative report was submitted for review.No current patient information has been submitted at this time.Without the actual products involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: LEGION PS OXIN FEM SZ6 RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED,CEMNTD,POLYMR/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7921373
• Report Number: 1020279-2018-01981
• Device Sequence Number: 13834550
• Product Code: JWH
• UDI-Device Identifier: 00885556029138
• UDI-Public: 00885556029138
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 09/22/2023
• Device Catalogue Number: 71421206
• Device Lot Number: 13JM15892
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/30/2018
• Supplement Report FDA Received Date: 05/01/2019
• 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: 57 YR