MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

Model Number	PHA04416
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	12/18/2023
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, breakage of the head after movement of patient.
Additional Manufacturer Narrative
Sectio b.5: additional information in description / section d.4: lot# has been updated/ d.5: implant and explant date added/h.6: health effect clinical code added.
Event or Problem Description
Allegedly, breakage of the head after movement of patient.Update (b)(6), 2024: 10 months after the surgery the patient referrals pain and functional limitations when loading the limb.Possible traumatic event (jump, descent from a step) but the patient does not remember any specific one.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
• 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: 18466577
• Report Number: 3010536692-2024-00006
• Device Sequence Number: 20621703
• Product Code: LZO
• UDI-Device Identifier: M684PHA044161
• UDI-Public: M684PHA044161
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/17/2024

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: PHA04416
• Device Catalogue Number: PHA04416
• Device Lot Number: 1947598
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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 Sex: Unknown