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

Catalog Number PHA0-0232

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 07/28/2014

Event Type  Injury  

Event Description

Allegedly about 2 years post-op, the surgeon found loosening of the cup.As observation at the revision surgery, the surgeon couldn't remove the neck from the stem.Finally, the surgeon removed the neck with the stem.The surgeon wants us to investigate "the condition of the boundary surface by sem after mpo cuts the stem with neck in horizontal section".The surgeon wants to know whether it has corrosion, corrosion pitting or not.

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This event occurred in the (b)(6).This is the same event as 3010536692-2014-01202.

Manufacturer Narrative

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

• Brand Name: PROFEMUR(R) Z STEM
• 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: 4033869
• MDR Text Key: 4726481
• Report Number: 3010536692-2014-01203
• Device Sequence Number: 1
• Product Code: LPH
• 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: 08/13/2014

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?: Yes
• Device Operator: Other
• Device Catalogue Number: PHA0-0232
• Device Lot Number: 078653466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/28/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 08/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention