MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 8; KNEE INSTRUMENT

Model Number E1204108

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, turned the rotating dial on cutting to '0' position.At this point it had malfunction due anterior resection was off and notched the anterior cortex significantly, posterior resection did not align correctly.The cutting block and back plate, spring, and center dial popped out were removed.It was confirmed that due to this instrument breaking, the femoral bone was cut incorrectly leading to a revision of the components in surgery and a 2.5 hour delay.Also, only one set of implants was used in the surgery and they were implanted.

• Brand Name: EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 8
• Type of Device: KNEE INSTRUMENT
• 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: 14348221
• MDR Text Key: 291348733
• Report Number: 3010536692-2022-00161
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: M684E12041081
• UDI-Public: M684E12041081
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: E1204108
• Device Catalogue Number: E1204108
• Device Lot Number: 1323023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2022
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male