MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL NECK SLEEVE; HIP COMPONENT

Model Number 38NS-3500

Device Problem Insufficient Information (3190)

Patient Problems Synovitis (2094); Reaction (2414); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revised, intra-operative and pathological findings included reactive synovitis throughout.Recurrent pseudo-tumor formation with fluid and irritation of the iliopsoas tendon bursa.(right).Products not revised: (from original surgery).Conserve® biofoam cup 38bf4652 1429745.Pofemur® z plasma stem pha00268 1469316.

Manufacturer Narrative

After the initial report it was determined that this product was reported in error.No complaint stated against the product.Please void the initial report.

• Brand Name: CONSERVE(R) TOTAL NECK SLEEVE
• 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: 7823987
• MDR Text Key: 118471222
• Report Number: 3010536692-2018-01117
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38NS-3500
• Device Catalogue Number: 38NS-3500
• Device Lot Number: 1692813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2018
• Date Manufacturer Received: 08/23/2018
• 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