MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROCOTYL PRIME BF QUAD SHELL 52 MM GROUP C; HIP COMPONENT

Model Number	P3SBQC52
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening of prosthetic hip.Medwatch number: mw5094811.

• Brand Name: PROCOTYL PRIME BF QUAD SHELL 52 MM GROUP C
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10270882
• Report Number: 3010536692-2020-00485
• Device Sequence Number: 3399453
• Product Code: LPH
• UDI-Device Identifier: M684P3SBQC521
• UDI-Public: M684P3SBQC521
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: Health Professional
• Device Model Number: P3SBQC52
• Device Catalogue Number: P3SBQC52
• Device Lot Number: 1811831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention