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

Model Number 38NS-0000

Device Problem Corroded (1131)

Patient Problems Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient suffering from cocr neck corrosion.(right).Additional information received from litigation on 08/06/2018.Allegedly the patient was revised due to cocr corrosion: pain; disability in function; fluid collection identified on mri; swelling; discomfort; intra-operative and pathological findings included gross purulence and necrotic/reactive tissue within the hip capsule.(right) confirms that this incident group components are for the right side not the left as originally reported.

• 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: 7819976
• MDR Text Key: 118337319
• Report Number: 3010536692-2018-01108
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38NS-0000
• Device Catalogue Number: 38NS-0000
• Device Lot Number: 1001227215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2018
• Date Manufacturer Received: 08/06/2018
• 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