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

Model Number DLCOGG44

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event Description

Allegedly, on (b)(6) 2008, plaintiff had a left hip implantation surgery.The wright medical hip components that were implanted included: a conserve plus cup cobalt-chromium cup (lot no.107476061); a profemur plasma z stem titanium stem (lot no.117488870); a profemur titanium neck (lot no.107484845); and, a conserve total a-class head cobalt-chromium head (lot no.087466397).On (b)(6) 2009 plaintiff underwent a revision surgery, in this surgery, the conserve plus cup was removed and replaced with a wright medical dynasty cup; the conserve total a-class headcobalt-chromium head was removed and replaced with a conserve a-class head cobalt-chromium head.On (b)(6) 2021, plaintiff had a revision surgery performed on his left hip.Dr.(b)(6) noted a massive pseudotumor and related it to metallosis.Dr.(b)(6), removed the wright medical components from plaintiff, revision surgery operative notes that the surgery took double the amount of time of normal revision hip replacement.Involved pseudotumor debridement and extensive exposure for stem removal.

• 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: 14376569
• MDR Text Key: 291518165
• Report Number: 3010536692-2022-00188
• 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,Foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLCOGG44
• Device Catalogue Number: DLCOGG44
• Device Lot Number: 039828320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2022
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male