MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP?SPIKE KEEL TOWER CEM 2+ - 8+; KNEE INSTRUMENT

Model Number	E2004028
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the instrument was used with the appropriate manor with the required tibial tray and impacted into the bone.Broaching was undertaken but the tibial punch tower seeemed to raise off the tibial base plate.Pushing down the tower the tibial keal was seated and bottomed out.When counting the instruments back into the trays it was noticed that the posteria lateral peg was missing from e2004028.This was after cemented implantation and at the time of sewing up.No metal remnant was seen protruding from or inside the pulse lavaged tibial surface prior to cementing the tibial plate.The patient was xrayed immediately post op to check for the peg remnant.It was not seen in the soft tissue nore was it seen in the bone on an ap & lat but it could obstructed by the metal keel of the tibial plate.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION® MP?SPIKE KEEL TOWER CEM 2+ - 8+
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17500122
• Report Number: 3010536692-2023-00150
• Device Sequence Number: 15051042
• Product Code: FZX
• UDI-Device Identifier: M684E20040281
• UDI-Public: M684E20040281
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/13/2023

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: E2004028
• Device Catalogue Number: E2004028
• Device Lot Number: CN103106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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: 82 YR
• Patient Sex: Unknown