MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® Z STEM; HIP COMPONENT

Model Number PHA00238

Device Problem Loss of Osseointegration (2408)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, patient underwent in (b)(6) 2010 replacement of the right hip by means of a metal-metal prosthesis implantation, has developed pseudo-tumor from metal-metal coupling, with evidence of a cobalt dosage of 7.7 mg / l (compared to reference <1.0mg / l), causing aseptic loosening of the prosthesis and forcing it to undergo a prosthetic revision in 2014, of increased complexity due to the presence of the tumor mass.More tools since the onset of metallosis and, even more so, the development of pseudo-tumor represent clear typical consequences of metal / metal combinations.Only part numbers and lot numbers for the cup and stem were provided.

Manufacturer Narrative

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

Manufacturer Narrative

Due to additional information received for this event and after further analysis from reliability engineering, it has been determined that there is no an alleged deficiency against this device.Therefore, this device has been considering as no complaint stated and no longer reportable.Please void this report.

• Brand Name: PROFEMUR® Z STEM
• 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: 15469661
• MDR Text Key: 300428079
• Report Number: 3010536692-2022-00342
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 03/14/2023

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: PHA00238
• Device Catalogue Number: PHA00238
• Device Lot Number: 0701181789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2022
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 09/05/2022; 09/05/2022
• Supplement Dates FDA Received: 12/20/2022; 03/14/2023
• 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