MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to deep wound infection.Left hip.

• Brand Name: PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10503134
• Report Number: 3010536692-2020-00608
• Device Sequence Number: 3222152
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12141
• UDI-Public: M684PHAC12141
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: PHAC1214
• Device Catalogue Number: PHAC1214
• Device Lot Number: 1410387
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68