MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1; KNEE COMPONENT

Model Number	KIMP310L
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient's knee joint was worn and medial, the implanting physician tried to assemble the insert (lot.1881643), but failed; even if repeated attempts still do not work.Once being aware of the incident, the implanting physician switched to another product(lot.1878191) immediately.Although the operation was completed finally, the whole process was delayed for about 40 mins.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 LEFT 1
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14025384
• Report Number: 3010536692-2022-00106
• Device Sequence Number: 2646578
• Product Code: JWH
• UDI-Device Identifier: M684KIMP310L1
• UDI-Public: M684KIMP310L1
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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: KIMP310L
• Device Catalogue Number: KIMP310L
• Device Lot Number: 1881643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown