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

Model Number	PHA01254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, modular neck fracture left hip.It is not mentioned on initial report if a revision surgery has already been performed.A device with lot number: 0805msn0158 has been indicated to be related to this event however this lot number does not correspond to an actual microport orthopedics product.
Event or Problem Description
Allegedly, modular neck fracture left hip.Additional information received on 2023-07-06: the patient suddenly felt pain in the area of the left hip without trauma since then he can no longer put full weight on the left hip.Non-mpo components: product id: 0805m8n0158 implantec gmbh of grenzgasse 38a, 2340 mödling/ lot number: 90621-a/ qty: (b)(4).

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• 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: 17043383
• Report Number: 3010536692-2023-00104
• Device Sequence Number: 5130275
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 039831013
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 05/11/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/12/2023; 11/03/2023
• 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 Sex: Unknown