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	Insufficient Information (4580)
Date of Event	07/10/2021
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, on or about (b)(6) 2021, patient returned to his orthopedist and x-rays of the right hip revealed, the stem of the arthroplasty has fractured.On or about (b)(6) 2021, due to "failure of recalled hardware of the right total hip arthroplasty patient underwent a right hip replacement.The profemur® total hip system implanted on plaintiffs right side failed due to fracture of the modular neck.Patient orthopedic surgeon found the "femoral trunnion was fractured directly, at the level of its insertion into the modular femur." additionally, intraoperative findings reflect that patient orthopedic surgeon made several attempts to remove the well-fixed femoral stem, and as such surgical dissection, exposure, and implant placement took two times longer given the technical difficulty.Patient surgeon further noted a combination of osteomas and bur were used to try and dissociate the femoral component from the bone on growth.Patient developed further complications a result of the revision surgery.On or about (b)(6) 2021, plaintiff suffered a right hip dislocation.Additionally, on or about (b)(6) 2021, plaintiff suffered another right hip dislocation.
Additional Manufacturer Narrative
Section d.6a: explant date has been updated.

• 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 Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 17016878
• Report Number: 3010536692-2023-00098
• Device Sequence Number: 12336210
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12541
• UDI-Public: M684PHAC12541
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

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: PHAC1254
• Device Catalogue Number: PHAC1254
• Device Lot Number: 1503097
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 06/27/2023
• 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-2743-2015
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male