MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) NECK A/R 15DG LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when the investigation is complete.
Event or Problem Description
Allegedly, patient was revised from a total hip due to a psuedo-tumor.
Event or Problem Description
Allegedly, patient was revised from a total hip due to a psuedo-tumor.

• Brand Name: PROFEMUR(R) NECK A/R 15DG LONG COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9354515
• Report Number: 3010536692-2019-01146
• Device Sequence Number: 19390713
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12441
• UDI-Public: M684PHAC12441
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: PHAC1244
• Device Catalogue Number: PHAC1244
• Device Lot Number: 1426839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR