MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT; KNEE COMPONENT

Model Number	KIMP410R
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, after opening the package of the liner, the nurse found the inside package was not sealed.The part was supposed to be sealed inside the white bag for sterilization purpose to avoid contamination.However, the part inside is exposed to the air directly.The sterilization cannot be guaranteed.Once being aware of the incident, distributor started to prepare the spared part at the first moment.Although the operation was completed finally, the whole process was delayed for more than 1.5 hours, which might have negative effects to the patient.

• Brand Name: ADVANCE II MEDIAL PIVOT TIBIAL INSERT SZ 4 RIGHT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11697764
• Report Number: 3010536692-2021-00218
• Device Sequence Number: 14311759
• Product Code: JWH
• UDI-Device Identifier: M684KIMP410R1
• UDI-Public: M684KIMP410R1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K972770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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?: No
• Operator of Device: Other
• Device Model Number: KIMP410R
• Device Catalogue Number: KIMP410R
• Device Lot Number: 1851344
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/30/2021
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR