MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHEM FEMORAL PS COCR SZ 3 RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 71422833

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, it was noticed that the packaging tray of the anthem femoral ps cocr sz 3 is dented.Surgery was performed, after a non-significant delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting.The information states that, even though the packaging of the device was dented, the sterile barrier remained intact.It was determined that this case does not meet the threshold for reporting and is a non-reportable event.H11: corrected information in h6 (medical device problem code).

• Brand Name: ANTHEM FEMORAL PS COCR SZ 3 RT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15372018
• MDR Text Key: 305597468
• Report Number: 1020279-2022-03993
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556531303
• UDI-Public: 00885556531303
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K142807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71422833
• Device Catalogue Number: 71422833
• Device Lot Number: 22DB00299
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1