MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) Z STEM PLASMA SPRAYED; HIP COMPONENT

Catalog Number PHA0-0260

Device Problem Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Synovitis (2094); Complaint, Ill-Defined (2331)

Event Date 11/08/2013

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01112, -01113, -01114, -01116, -01117, -01118.

Event Description

Allegedly, patient was revised due to mom complications: pain; pseudotumor and metallosis; pseudocapsule with dark murky fluid; metallosis and synovitis tissue; necrotic bone and focal fibrohistiocytic granulomatous; infection; re-revision a pseudocapsule, metallosis and pus was recovered: left.

Manufacturer Narrative

Complaint database was reviewed and no trend for item/lot was identified.

• Brand Name: PROFEMUR(R) Z STEM PLASMA SPRAYED
• 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: 4798790
• MDR Text Key: 15257848
• Report Number: 3010536692-2015-01115
• Device Sequence Number: 1
• Product Code: LPH
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

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: PHA0-0260
• Device Lot Number: 125299187
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/08/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• 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: 71 YR