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

Model Number	PHA01222
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	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 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
• 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: 13358105
• Report Number: 3010536692-2022-00024
• Device Sequence Number: 4646399
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012221
• UDI-Public: M684PHA012221
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/01/2022
• 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: Male