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

Model Number PHA01254

Device Problem Break (1069)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 04/14/2023

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 316382121
• Report Number: 3010536692-2023-00104
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Removal/Correction Number: Z-2941-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention