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

Model Number 38025056

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, the patient was revised due to metallosis (no pseudotumor) and the failure of modular neck at the neck/stem junction taper (neck broken).

Event Description

Allegedly, the patient was revised due to failure of the modular neck at the neck/stem junction taper (fractured neck).The revision operative notes also lists, "moderate metallosis (no pseudotumor)" as an intraoperative finding.

Manufacturer Narrative

Updated incident description.All previous information including the investigation remains the same.

• Brand Name: CONSERVE PLUS CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11585618
• MDR Text Key: 242884166
• Report Number: 3010536692-2021-00179
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38025056
• Device Catalogue Number: 38025056
• Device Lot Number: 094104970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2021
• Date Manufacturer Received: 03/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR