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

Catalog Number PHA0-1234

Device Problem Insufficient Information (3190)

Patient Problem Seroma (2069)

Event Date 06/16/2014

Event Type  Injury  

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

Event Description

Allegedly patient was revised due to a pseudotumor.

Manufacturer Narrative

Investigation is not complete.Trends will be evaluated.This is the same event as 3010536692-2014-01157.This report will be updated when the investigation is complete.This event occurred in (b)(6).

• 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: 4014789
• MDR Text Key: 12567380
• Report Number: 3010536692-2014-01158
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2014

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: PHA0-1234
• Device Lot Number: 029784227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/16/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 08/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 47