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

Model Number PHA01222

Device Problem Corroded (1131)

Patient Problem 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 started to experience pain in or around his right hip joint, along with cobalt and chromium levels that were increasing over the past few years.Continuing and increasing pain in his right hip, and elevated serum cobalt/chromium levels reported on (b)(6) 2019.In the (b)(6) 2019, right hip revision procedure patient´s right hip was revised, resulting in removal and replacement of the previously implanted conserve-dynasty-profemur hip system metal-on-metal bearing surface with a biomet dual mobility active articulation hip system, and a microport alumina matric composite delta option head, and a delta option neck sleeve.An operative note from the (b)(6) 2019, revision procedure references a finding of stained synovium and significant corrosion on the modular neck.The extracted modular neck shows significant corrosion on both the proximal and distal trunnions of that device.Due to concerns with a history of the wright medical titanium profemur modular necks corroding, and fracturing, the intra-operative medical decision was also made by surgeon to remove and replace the titanium profemur modular neck of that hip with a new, not yet corroding, titanium modular neck.

• 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: 13358105
• MDR Text Key: 288671905
• Report Number: 3010536692-2022-00024
• Device Sequence Number: 1
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012221
• UDI-Public: M684PHA012221
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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: PHA01222
• Device Catalogue Number: PHA01222
• Device Lot Number: 117498738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/04/2022
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 04/01/2022
• 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
• Patient Sex: Male