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 Type  Injury  

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

The products were returned for evaluation.This complaint is confirmed.There were no trends identified.This issue will continue to be monitored through complaint tracking.

Event Description

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

• 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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 8333334
• MDR Text Key: 135953285
• Report Number: 3010536692-2019-00377
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• 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: 1781726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/29/2019
• Date Manufacturer Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention