MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK A/R VAR/VAL 1 SHORT COBALT CHROME; HIP COMPONENT

Model Number	PHAC1222
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient underwent revision surgery on right hip due to corrosion at the neck-stem junction, pain and elevated cobalt and chromium levels.Dr.Penenberg removed and replaced the wright profemur cocr modular neck, wright acetabular head, and polyethylene liner of plaintiff's artificial hip.Products not revised: part id: pha00242 profemur® z femoral stem s 6 cement less/ lot number: 0511353146/ qty:1.

• Brand Name: PROFEMUR® NECK A/R VAR/VAL 1 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: 14197247
• Report Number: 3010536692-2022-00138
• Device Sequence Number: 4332575
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12221
• UDI-Public: M684PHAC12221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: PHAC1222
• Device Catalogue Number: PHAC1222
• Device Lot Number: 311316435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 07/06/2022
• 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 Sex: Unknown