MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD; HIP COMPONENT

Model Number 2600-00XX

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per article by winston, et al., arthrolast today.2016 dec 1;3(2):77-82: allegedly a (b)(6) woman with a profemur z-gb mod stem, a profemur ti modular neck, a lineage shell, and a biolox forte ceramic-on-ceramic bearing underwent a revision for pain and significant decreased range of motion 11 years post-operation.Patient reported symptoms started 1 year post-operation and used a wheelchair for several years prior to being seen by the revision surgeon team.Revision surgery found metallosis and pelvic osteolysis resulting in a pelvic discontinuity.

Manufacturer Narrative

After the initial and follow up report it was determined that the complaint allege a deficiency against the liner.This was previously reported under mdr 3010536692-2018-00902.Please void the initial and follow up reports.

• Brand Name: FEMORAL HEAD
• 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: 7665173
• MDR Text Key: 113271160
• Report Number: 3010536692-2018-00903
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• PMA/PMN Number: K002149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2600-00XX
• Device Catalogue Number: 2600-00XX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2018
• Date Manufacturer Received: 06/26/2018
• 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: 70 YR