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 Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	10/12/2021
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, the patient's knee joint was worn and medial, the implanting physician tried to assemble the insert, but failed; even if repeated attempts still do not work.And the method of dislocation of femur was not effective.Once being aware of the incident, the implanting physician switched to another product immediately.Although the operation was completed finally, the whole process was delayed for about 30 mins.Additional information 27-oct-2021: another insert (same part/same lot) was successfully implanted.A part from this same part/lot will be returned for analysis.Based on sales data from (b)(4), 2 parts with this same part/lot have been successfully implanted.One is involved in this complaint.

• 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: 12756310
• Report Number: 3010536692-2021-00558
• Device Sequence Number: 3310288
• 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
• 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): 03/08/2022

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: 1885705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 03/08/2022
• 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 Age: 69 YR
• Patient Sex: Male