MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION CR NP NARROW FEM SZ 5 LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	71933642
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, the surgeon did not feel that the implant was actually the required one, a legion cr np narrow femur sz 5 lt, like it said on the box.It is suspected that the implant was miss-packaged.The procedure was finished using the same device, with no surgical delay.The patient outcome is unknown.
Additional Manufacturer Narrative
H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that the doctor commented that he didn't feel the implant was actually a narrow femur, like it says on the box, and suspects the implant is miss-packaged.Per email communication, the procedure was completed using the same device, with no surgical delay or injury to the patient.A review of complaint history did not reveal additional complaints for the listed batch.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 product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Potential probable causes could be but are not limited to procedural variants and user error.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.

• Brand Name: LEGION CR NP NARROW FEM SZ 5 LT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10273494
• Report Number: 1020279-2020-03200
• Device Sequence Number: 19679295
• Product Code: JWH
• UDI-Device Identifier: 00885556063187
• UDI-Public: 00885556063187
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71933642
• Device Catalogue Number: 71933642
• Device Lot Number: 20CM09666
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1