MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR FEMORAL NECK; HIP COMPONENT

Model Number PHA01204

Device Problem Corroded (1131)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient experienced pain in his hip and testing revealed high cobalt levels that could lead to cobalt poisoning.Additional information received on 07/11/2022: patient underwent index surgery on his right hip on (b)(6) 2006.Patient subsequently underwent revision surgery on (b)(6) 2019.He alleges cocr corrosion at the neck/stem junction, but he did not receive a cocr neck or stem.He does allege elevated metal ions, and he did receive mom head/cup devices.

• Brand Name: PROFEMUR® MODULAR FEMORAL NECK
• 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: 15105392
• MDR Text Key: 296606604
• Report Number: 3010536692-2022-00257
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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
• Device Operator: Other
• Device Model Number: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: U0785237
• 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
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 09/05/2022
• 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