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

Model Number	P3CIMPAD
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Allegedly, devices had blood waste from previous operations.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PRIME CUP IMPACTION PORTAL ADAPTER
• Common Device Name: 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
• Report Number: 3010536692-2021-00550
• Device Sequence Number: 17340321
• Product Code: LXH
• UDI-Device Identifier: M684P3CIMPAD1
• UDI-Public: M684P3CIMPAD1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown