MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION PS OXIN FEM SZ6 LT; PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY

Model Number	71421216
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, on (b)(6) 2020, 5 pieces of legion ps oxin fem sz6 lt was sent for material review board (mrb) evaluation due to handling/surface damage caused by a stoppage in the passivation machine transport system.Disposition instructions in the non-conformance indicated that the product should be returned to wet blast to be reworked.However, when reviewing the production order in sap, the order was not reworked but returned to the production floor under the original production order.This is being reported following the 21 cfr 803, a remedial action is being taken, there were no complaints for this issue.No patient involved.

• Brand Name: LEGION PS OXIN FEM SZ6 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMTIB, SEMI-CONSTRAINED, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11864553
• Report Number: 1020279-2021-04606
• Device Sequence Number: 1099064
• Product Code: JWH
• UDI-Device Identifier: 00885556030059
• UDI-Public: 00885556030059
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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?: Yes
• Operator of Device: No Information
• Device Model Number: 71421216
• Device Catalogue Number: 71421216
• Device Lot Number: 20HM17607
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1