MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER MEDIUM; HIP COMPONENT

Model Number 26000018

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Type  Injury  

Event Description

Allegedly, patient underwent right thr on (b)(6) 2020.Revised on (b)(6) 2020 due to dislocation.Surgeon reports the dislocation is most likely due to neutral version of the cup placement.Patient revised with a +7 cocr head and a 15 degree lip liner.(b)(6).

• Brand Name: COCR TRANSCEND FEMORAL HEAD 28MM SLT TAPER MEDIUM
• 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: 11171474
• MDR Text Key: 226849587
• Report Number: 3010536692-2021-00015
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M684260000181
• UDI-Public: M684260000181
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K004043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26000018
• Device Catalogue Number: 26000018
• Device Lot Number: 1837353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2020
• Date Manufacturer Received: 12/21/2020
• 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
• Patient Age: 87 YR