MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR NECK REMNANT EXTRACTION PLUG; HIP INSTRUMENT

Model Number	PRNEPLUG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly during dr.(b)(6) attempts at removing a broken neck the remnant extraction plug broke.It was after the tapping stage, during the extraction step that this instrument broke in conjunction with the neck extractor (cork screw).Force was applied to the neck extractor and the plug broke at the point it was decided to remove the stem when the new remnant could not be removed.(linked to complaint (b)(4)).Kit number: prnekit2.Lot number: 07.

• Brand Name: PROFEMUR® MODULAR NECK REMNANT EXTRACTION PLUG
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8881882
• Report Number: 3010536692-2019-01006
• Device Sequence Number: 1903398
• Product Code: HWB
• UDI-Device Identifier: M684PRNEPLUG1
• UDI-Public: M684PRNEPLUG1
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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: PRNEPLUG
• Device Catalogue Number: PRNEPLUG
• Device Lot Number: 1393142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2019
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/11/2019
• Supplement Report FDA Received Date: 05/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR