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

Model Number PHA00XXX

Device Problem Corroded (1131)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, the patient presented with pain and lack of mobility.The left-sided device failed due to corrosion at the neck-stem junction.At revision surgery, it was discovered that the device failed due to corrosion of the oblong taper of the profemur cocr modular neck where it seated in the pocket of the profemur titanium stem.

Manufacturer Narrative

Due to human error, this manufacturer incident report number: (b)(4) is a duplicate event of manufacturer incident report number: (b)(4).Please void this report.

• Brand Name: PROFEMUR® Z FEMORAL 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: 14282787
• MDR Text Key: 290699810
• Report Number: 3010536692-2022-00156
• Device Sequence Number: 1
• Product Code: LZO
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA00XXX
• Device Catalogue Number: PHA00XXX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2022
• Date Manufacturer Received: 04/11/2022
• 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: Female