MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS RESURFACING HEAD; HIP COMPONENT

Catalog Number 38XX-XXXX

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trends will be evaluated.

Event Description

Per paper by amstutz, et al., bone joint j.2017 jul;99-b(7):865-871: allegedly the male patient was revised for wear 120 months after primary.Patient was (b)(6) years of age at primary, with a primary indication of osteo-arthritis, a bmi of 30, and a head size of 48mm.The authors reported that the serum cobalt ion levels were 121.6 /l and the serum chromium ion levels were 61.9 /l.

• Brand Name: CONSERVE(R) PLUS RESURFACING 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: 6762151
• MDR Text Key: 81663220
• Report Number: 3010536692-2017-00972
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38XX-XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/31/2017
• Date Manufacturer Received: 07/31/2017
• 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: 40 YR