MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR OXIN FEM SZ3 LT; PRSTHSSKNEPATLLOFMROTBLSMICNSTRNDCMNTDPLYMR/MTAL/PLYMR

Model Number	71421233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, black particles were stuck to the cement while cementing legion a oxonium femoral component.No delay.No backup device available.No impact or injury to patient reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation, the reported event could not be confirmed.The photo provided confirmed residue on the cement.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Possible probable causes could be loss of sterility, packaging, or manufacturing.Product was sterilized according to sterilization release documentation from quality control.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.
Event or Problem Description
It was reported that during surgery, black particles were stuck to the cement while cementing a legion oxinium femoral component.The black particles were removed with a sterile solution.The procedure was completed with the same device.No delay.No backup device available.No injury to patient reported.

• Brand Name: LEGION CR OXIN FEM SZ3 LT
• Common Device Name: PRSTHSSKNEPATLLOFMROTBLSMICNSTRNDCMNTDPLYMR/MTAL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9580519
• Report Number: 1020279-2020-00233
• Device Sequence Number: 16258125
• Product Code: JWH
• UDI-Device Identifier: 00885556030240
• UDI-Public: 00885556030240
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K043440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: Health Professional
• Device Model Number: 71421233
• Device Catalogue Number: 71421233
• Device Lot Number: 19CM07425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR