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

Catalog Number PHA0-1242

Device Problem Corroded (1131)

Patient Problems Pain (1994); Swelling (2091); Toxicity (2333)

Event Date 08/29/2014

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01362, -01363, -01364.

Event Description

Allegedly patient was revised due to mom complications; pain, alval lesion; : elevated blood and chromium ion levels; metal tattooing of the pseudocapsule; large straw-colored fluid collection; corrosion at the head-neck left.

Manufacturer Narrative

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

• 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 ; 9018674771
• MDR Report Key: 5244421
• MDR Text Key: 31968185
• Report Number: 3010536692-2015-01970
• 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: 11/23/2015

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: PHA0-1242
• Device Lot Number: 046337078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/29/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• 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: 65 YR