MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL® PRIME BF QUAD SHELL 46 MM GROUP B; HIP COMPONENT

Model Number	P3SBQB46
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2023
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, radiolucency around cup of left hip possibly indicating component loosening.

• Brand Name: PROCOTYL® PRIME BF QUAD SHELL 46 MM GROUP B
• 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: 19149121
• Report Number: 3010536692-2024-00273
• Device Sequence Number: 7960063
• Product Code: LPH
• UDI-Device Identifier: M684P3SBQB461
• UDI-Public: M684P3SBQB461
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 08/09/2024

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: P3SBQB46
• Device Catalogue Number: P3SBQB46
• Device Lot Number: 1841488
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 45 KG