MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SLT TAPER COBALT-CHROME FEMORAL HEAD; HIP COMPONENT

Model Number 2601-2601

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

The complaint will be updated once the investigation is completed.Trends will be evaluated.

Event Description

Allegedly primary surgery was performed at (b)(6) 2019.The surgeon found a dissociation after surgery.The surgeon will be performed revision surgery at (b)(6) 2019.We will return cup, head and stem.

Event Description

Allegedly primary surgery was performed on (b)(6) 2019.The surgeon found a dissociation after surgery.The surgeon will be performed revision surgery on (b)(6) 2019.We will return cup, head and stem.

• Brand Name: SLT TAPER COBALT-CHROME FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8523805
• MDR Text Key: 142247755
• Report Number: 3010536692-2019-00655
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2601-2601
• Device Catalogue Number: 2601-2601
• Device Lot Number: 1779982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2019
• Date Manufacturer Received: 03/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR