MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R 8DG LONG COBALT CHROME; HIP COMPONENT

Model Number PHAC1234

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Additional information regarding dislocation / subluxation and infection changes the reportability status of this component.

Event Description

Allegedly, the acetabular component was inserted as a revision for a previously migrated procotyl l shell.Revision component inserted in routine fashion and secured with 3x screws.Shell insertion and screw insertion appeared secure at completion of procedure.Patient seen in routine follow up clinic at 3 months just 2 days before readmission with further migration of revision acetabular component.Patient denies any traumatic event.The previous revision is captured under incident group (b)(4).Additional information: allegedly, as reported from uk njr registry data, this patient was revised due to dislocation and/or subluxation and infection.Srnjr reference: (b)(4).

• Brand Name: PROFEMUR® NECK A/R 8DG LONG COBALT CHROME
• 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: 15351254
• MDR Text Key: 299212345
• Report Number: 3010536692-2022-00311
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12341
• UDI-Public: M684PHAC12341
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHAC1234
• Device Catalogue Number: PHAC1234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2022
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female