MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL A-CLASS HEAD; HIP COMPONENT

Catalog Number 38AM-4435

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Malposition of Device (2616)

Patient Problem Tissue Damage (2104)

Event Date 05/05/2015

Event Type  Injury  

Manufacturer Narrative

This is the same event as 3010536692-2015-01280 and 01478.

Event Description

Allegedly the metal liner was either never seated or it somehow came loose and rotated.The liner slipped out of the shell when it was exposed.There was a lot of black tissue discovered.

• Brand Name: CONSERVE(R) TOTAL A-CLASS HEAD
• 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 ; 901867-477
• MDR Report Key: 4992162
• MDR Text Key: 22569843
• Report Number: 3010536692-2015-01477
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 38AM-4435
• Device Lot Number: 128755737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/11/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2015
• 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: 73 YR