MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1202
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, immunological reaction alval type (aseptic lymphocytic vasculitis associated lesion) probably linked to metallic particles with a cobalt allergy suspicion (positive skin reaction).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: PROFEMUR® NECK NEUTRAL SHORT COBALT CHROME
• Common Device Name: HIP COMPONENT
• 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: 15131799
• Report Number: 3010536692-2022-00260
• Device Sequence Number: 14869452
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12021
• UDI-Public: M684PHAC12021
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

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: PHAC1202
• Device Catalogue Number: PHAC1202
• Device Lot Number: 1493540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 86 KG