MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL® PRIME BF QUAD SHELL 56 MM GROUP D; HIP COMPONENT

Model Number P3SBQD56

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 04/28/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, continued pain in left hip.Prosthesis in good position 3-weeks post-op, with subsidence of stem noted at 3-months post-op.No fracture or signs of infection.No change to implant position at 6-months.

• Brand Name: PROCOTYL® PRIME BF QUAD SHELL 56 MM GROUP D
• 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: 19201338
• MDR Text Key: 341259673
• Report Number: 3010536692-2024-00276
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: M684P3SBQD561
• UDI-Public: M684P3SBQD561
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P3SBQD56
• Device Catalogue Number: P3SBQD56
• Device Lot Number: 1843436
• 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?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 95 KG