MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY COCR LINER; HIP COMPONENT

Model Number DLCOGF42

Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

See investigation attached.

Event Description

Allegedly, the patient was revised due to metal on metal complications on articulating cobalt chrome components.Components not revised: profemur® z femoral stem s 41/3 tp coated cement less / product id: pha00266 / lot no.: 068599981.Dynasty® pc shell 56mm group f / product id: dspcgf56 / lot no.: 107475199.Cancellous self-tapping 6.5mm bone screw 4.0cm length / product id: 18080305 / lot no.: 078661945.

• Brand Name: DYNASTY COCR LINER
• 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: 11655380
• MDR Text Key: 245090994
• Report Number: 3010536692-2021-00196
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLCOGF42
• Device Catalogue Number: DLCOGF42
• Device Lot Number: 01739617010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2021
• Date Manufacturer Received: 04/02/2021
• 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