MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PRIME CUP IMPACTION PORTAL ADAPTER; HIP INSTRUMENT

Model Number P3CIMPAD

Device Problem Residue After Decontamination (2325)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

Allegedly, devices had blood waste from previous operations.

Manufacturer Narrative

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

• Brand Name: PRIME CUP IMPACTION PORTAL ADAPTER
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12716537
• MDR Text Key: 280941683
• Report Number: 3010536692-2021-00550
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: M684P3CIMPAD1
• UDI-Public: M684P3CIMPAD1
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P3CIMPAD
• Device Catalogue Number: P3CIMPAD
• Device Lot Number: G190751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2021
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention