MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1204
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient bent over and felt a cracking sensation in his left hip and a sagging of his left leg.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, the patient bent over and felt a cracking sensation in his left hip and a sagging of his left leg.Additional information received on 12-20-2023: revision due to broken neck.Additional information received on 05-21-2024: bfarm sends the implant card with all the products.Non revised products: product id: prglha07 profemur® gladiator® ha stem w/ collar sz 7/ lot number: 1595955/ qty: 1.Product id: pha04614 rim-lock "a-class®" acetabular poly liner 0° size 36 group g/ lot number: 15460181567319/ qty: 1.Product id: pha06222 acetabular cup "procotyl® l" beaded coated s.62 group g/ lot number: 078587711/ qty: 1.

• Brand Name: PROFEMUR® NECK NEUTRAL 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: 18573279
• Report Number: 3010536692-2024-00040
• Device Sequence Number: 7852778
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12041
• UDI-Public: M684PHAC12041
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: PHAC1204
• Device Catalogue Number: PHAC1204
• Device Lot Number: 1588245
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 08/15/2024
• 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 Age: 58 YR
• Patient Sex: Male