MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE PLUS CUP; HIP COMPONENT

Model Number 38024854

Device Problems Material Disintegration (1177); Loss of Osseointegration (2408)

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

See investigation attached.(b)(4).

Event Description

Allegedly, patient was revised due to acetabular component loosening, metallosis with probable adverse tissue reaction and elevated ions levels of his right hip.

• Brand Name: CONSERVE PLUS CUP
• 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: 10400914
• MDR Text Key: 202697125
• Report Number: 3010536692-2020-00567
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38024854
• Device Catalogue Number: 38024854
• Device Lot Number: 088632905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2020
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention