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

Model Number	PHAC1254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/03/2022
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, the patient reported sudden pain in the right hip and inability to exercise when getting up from a sitting position.X-ray evidence of the cone fracture.Bfarm case number: (b)(4).
Additional Manufacturer Narrative
Section b.4: the description has been updated/ section h.6: investigation codes has been updated.
Event or Problem Description
Allegedly, the patient reported sudden pain in the right hip and inability to exercise when getting up from a sitting position.X-ray evidence of the cone fracture.Additional information received on 03/26/2024: x-ray overview of the pelvis and hip joint on the right axial from (b)(6) 2022: the pelvic overview image shows that the implanted prosthesis on the left is properly seated.However, there is a fracture of the femoral neck fragment of the right prosthesis when it is seated properly the shaft and the socket.Bfarm case number: (b)(4).

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG LONG COBALT CHROME
• 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: 13693884
• Report Number: 3010536692-2022-00069
• Device Sequence Number: 5046514
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2024

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: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 0611366407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022; Not provided
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 05/07/2022; 06/05/2024
• 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-2743-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male