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

Catalog Number PHA0-1222

Device Problems Loose or Intermittent Connection (1371); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Osteolysis (2377); Ambulation Difficulties (2544)

Event Date 10/15/2009

Event Type  Injury  

Event Description

Allegedly, patient was revise due to acetabular loosening/pain; murky fluid build up.Post op: bone loss/particle disease, ambulatory difficulty; osteolysis.- right.

Manufacturer Narrative

See attached.This is the same event as 3010536692-2015-00744, -00745.- attachment: [wd011615.Pdf].

• 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 ; 901867-441
• MDR Report Key: 4737088
• MDR Text Key: 5709175
• Report Number: 3010536692-2015-00746
• 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
• Report Date: 04/08/2015

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: Physician
• Device Catalogue Number: PHA0-1222
• Device Lot Number: 095251023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/15/2009
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/29/2015
• 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: 63 YR