MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL BCH FEMORAL HEAD; HIP COMPONENT

Catalog Number 38CH-4400

Device Problems Device Slipped (1584); Failure to Align (2522); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/24/2015

Event Type  Injury  

Manufacturer Narrative

This is the same event as 3010536692-2016-00132 & 3010536692-2016-00133.This report will be updated when investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was revised due to mom complications.Additional information received on (b)(6) 2016.Allegedly the patient was revised due to the following mom complications: pain; loosening; acetabular cup was grossly loose and malaligned with absolutely no bone ingrowth; trochanteric and periarticular cyst formation; hemosiderin throughout the hip; grossly cheesy material around the proximal femur and trochanteric region.(left).

• Brand Name: CONSERVE(R) TOTAL BCH FEMORAL 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 ; 9018674771
• MDR Report Key: 5639729
• MDR Text Key: 44687897
• Report Number: 3010536692-2016-00665
• Device Sequence Number: 1
• Product Code: LZO
• 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
• Report Date: 05/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 38CH-4400
• Device Lot Number: 1539747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/08/2016
• Initial Date Manufacturer Received: 04/08/2016
• Initial Date FDA Received: 05/09/2016
• 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 Age: 76 YR