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

Model Number PHA01232

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the head dislocated from the cup and during repair, the neck disassociated from the stem.On monday, march 21, surgeon tried to repair the dislocation, after 30 minutes, it could not be repaired, and later, the disassociation was confirmed by x-ray.Doctor's finding:the patient may have disassociated during the traction movement at the time of the repair.Component not revised: prtl0026 / profemur tl stem size6 / lot 17230401908970 / qty 1.(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 (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 14134785
• MDR Text Key: 289429280
• Report Number: 3010536692-2022-00126
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012321
• UDI-Public: M684PHA012321
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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
• Device Operator: Other
• Device Model Number: PHA01232
• Device Catalogue Number: PHA01232
• Device Lot Number: 1902277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2022
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR
• Patient Sex: Female