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

Model Number PHAC1222

Device Problem Corroded (1131)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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
• Type of Device: 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
• MDR Text Key: 290695123
• Report Number: 3010536692-2022-00138
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12221
• UDI-Public: M684PHAC12221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention