MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? PS INSERT SIZE 4 STANDARD 12MM RIGH; KNEE COMPONENT

Model Number	EIP4S12R
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2021
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, during operation, insert cannot be assembled.Surgeon changed a thicker one to continue.It's suspected by the surgeon the failure was caused due to the insert.Surgery extended more than 30 minutes.
Additional Manufacturer Narrative
Void report: initially, a delay of more than 30 min was reported.Additional information from reporter on 12/15 indicated that the delay was of 20 min.Therefore, no serious injury has occurred.

• Brand Name: EVOLUTION® MP? PS INSERT SIZE 4 STANDARD 12MM RIGH
• 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: 12908592
• Report Number: 3010536692-2021-00572
• Device Sequence Number: 4982351
• Product Code: HRY
• UDI-Device Identifier: M684EIP4S12R1
• UDI-Public: M684EIP4S12R1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093552
• 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): 12/20/2021

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?: Yes
• Operator of Device: Other
• Device Model Number: EIP4S12R
• Device Catalogue Number: EIP4S12R
• Device Lot Number: 1656980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/20/2021
• 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
• Patient Sex: Unknown