MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01254
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
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, ti modular neck broke when pt picked up a potted plant.Attempted to remove with mpo remnant removal tray, 2 drill bits and a tap broke in the process.Surgeon also attempted to bur out neck with metal bur, this also did not work.Surgeon also attempted to remove with osteotomes, this did not work.After 4 hours the surgeon was finally able to remove the stem by performing an eto.Implants not revised: partid: conserve® plus cup 56mm id 62mm od beaded,item#38025662, lot#087457365, qty:1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, ti modular neck broke when pt picked up a potted plant.Attempted to remove with mpo remnant removal tray, 2 drill bits and a tap broke in the process.Surgeon also attempted to bur out neck with metal bur, this also did not work.Surgeon also attempted to remove with osteotomes, this did not work.After 4 hours the surgeon was finally able to remove the stem by performing an eto.Implants not revised: partid: conserve® plus cup 56mm id 62mm od beaded,item#38025662, lot#087457365, qty:1.
Additional Manufacturer Narrative
A minor change in section h.3, in the initial report the selection "no" was checked and changed to no returned to manufacturer.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: HIP 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: 13473311
• Report Number: 3010536692-2022-00043
• Device Sequence Number: 2084995
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 086371028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2941-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 159 KG