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

Model Number P3SBQB46

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, radiolucency around cup of left hip possibly indicating component loosening.

• Brand Name: PROCOTYL® PRIME BF QUAD SHELL 46 MM GROUP B
• Type of Device: 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
• MDR Text Key: 340673270
• Report Number: 3010536692-2024-00273
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684P3SBQB461
• UDI-Public: M684P3SBQB461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 45 KG