MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS SUPER FINISH FEMORAL; HIP COMPONENT

Model Number 3802-1052

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Conserve plus femoral component was loose and stem broken off in the femoral head.Conserve acetabulum component was checked for loss ending, but the shell was well incorporated to acetabular bone.Femoral head was resected.Profemur tl classic long straight neck ( cat#prtl-el27 lot# 1706717 ) with conserve a-class head, short neck ( cat.# 3801-5200, lot #0941067751459502 ) were implanted.Hip joint reduced and closed.Dr (b)(6) was happy with stability.

• Brand Name: CONSERVE(R) PLUS SUPER FINISH FEMORAL
• 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: 7500780
• MDR Text Key: 107817196
• Report Number: 3010536692-2018-00598
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3802-1052
• Device Catalogue Number: 3802-1052
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR