MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, fracture of a modular neck (ar vv1 long) on (b)(6) 2023.Revision surgery on (b)(6) 2023 (at clinic (b)(6), dr.(b)(6)).Additional information 02/05/2023: allegedly, patient suffered a spontaneous fracture of the modular neck while walking.There were no prior indications of this occurrence, no pain or restriction of movement.Since the broken neck could not be removed during the reoperation, the prosthesis shaft had to be revised and the femur opened.A revision hip stem was used.The surgeon dr.(b)(6) has been using mpo (formerly wright) modularity for almost 30 years and affirmed that he had followed all specifications regarding implant "modularity".The incident is reported by dr.(b)(6) reported to the responsible authorities (federal institute for drugs and medical devices, bfarm).Since the patient was and is compliant, the implant failure is inexplicable for the patient, and he indicated to the surgeon that legal action should be taken against the surgeon and the manufacturer.After the patient's rehab, at the end of february, he also expressed contact with his legal counsel.He also indicated that he could imagine an out-of-court settlement.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 1 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: 16443317
• Report Number: 3010536692-2023-00026
• Device Sequence Number: 17496975
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12241
• UDI-Public: M684PHAC12241
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: PHAC1224
• Device Catalogue Number: PHAC1224
• Device Lot Number: 0411333166
• 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: 02/05/2023
• Supplement Date Received by Manufacturer: 02/05/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male