MAUDE Adverse Event Report: TOTAL JOINT ORTHOPEDICS, INC. KLASSIC® FEMUR WITH COBALT 3D, SIZE 6; KNEE FEMUR

Model Number	5106.06.000
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in a total knee arthroplasty case, upon opening and inspection of the packaging per the ifu, it was noticed that the inner packaging of a knee femur was damaged, the implant was not opened or used in surgery.A second identical implant was inspected and opened without report of issue.Surgery was performed, without any delay, there was no impact to the patient.

• Brand Name: KLASSIC® FEMUR WITH COBALT 3D, SIZE 6
• Common Device Name: KNEE FEMUR
• Manufacturer (Section D): TOTAL JOINT ORTHOPEDICS, INC.; 1567 e stratford avenue; salt lake city UT 84106
• Manufacturer Contact: bobbi siddoway ; 1567 e stratford avenue; sale lake city, UT 84106 ; 8014866070
• MDR Report Key: 13635011
• Report Number: 3008544874-2022-00003
• Device Sequence Number: 2174563
• Product Code: MBH
• UDI-Device Identifier: 00814703016752
• UDI-Public: 00814703016752
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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: 5106.06.000
• Device Catalogue Number: 5106.06.000
• Device Lot Number: Q210415-7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown