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

Model Number EIP4S12R

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 281581659
• Report Number: 3010536692-2021-00572
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIP4S12R1
• UDI-Public: M684EIP4S12R1
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1