MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ7 RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71421207
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to severe metallosis.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis was conducted and the returned devices were examined visually.No destructive analysis was performed.The returned components are damage, has deformation, gouging and scratches were observed on the articular surface of the femoral component.The articulating surface of the tibial insert was also damaged and scratched.These features observed on the tibial insert have been reported as being created by third-body particulate (bone cement, bone, etc.) in the joint space.Cement and bone particulate are known to be produced during a total knee arthroplasty (tka), even under carefully controlled conditions.Damage and scratches were observed on the tibial baseplate.Cement was observed on the tibial baseplate, femoral, and patella components.Scratches were also observed on the articulating surface of the patella component.No material or manufacturing deviations were observed during the investigation.A clinical evaluation was conducted and without the request clinical information a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-assessed.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LEGION PS OXIN FEM SZ7 RT
• 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: 8604090
• Report Number: 1020279-2019-01891
• Device Sequence Number: 14040883
• Product Code: JWH
• UDI-Device Identifier: 00885556029404
• UDI-Public: 00885556029404
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: 11/11/2023
• Device Catalogue Number: 71421207
• Device Lot Number: 13LM09492
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 12/17/2019
• 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: 50 YR
• Patient Weight: 85