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

Catalog Number PHA0-1202

Device Problems Device Slipped (1584); Metal Shedding Debris (1804)

Patient Problems Tissue Damage (2104); Osteolysis (2377); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 01/14/2015

Event Type  Injury  

Event Description

Allegedly right hip revised due to elevated cobalt levels; impaired gait and mobility; and evidence of metallosis with loosening of the acetabular component, periacetabular osteolysis, and soft tissue damage.

Manufacturer Narrative

This is the same event as 3010536692-2015-01056, -01057, -01059.

Manufacturer Narrative

(b)(4).

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• 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 ; 901867-477
• MDR Report Key: 4793275
• MDR Text Key: 5814007
• Report Number: 3010536692-2015-01058
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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 Catalogue Number: PHA0-1202
• Device Lot Number: 049843755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/14/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• 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 Age: 77 YR