MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER LONG N; HIP COMPONENT

Model Number	26000027
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent revision surgery on right hip due to corrosion at the neck-stem junction, pain and elevated cobalt and chromium levels.Dr.(b)(6) removed and replaced the wright profemur cocr modular neck, wright acetabular head, and polyethylene liner of plaintiff's artificial hip.Products not revised: partid: pha00242 profemur® z femoral stem s 6 cement less/ lot number: 0511353146/ qty:1.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER LONG N
• Common Device Name: 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: 14212833
• Report Number: 3010536692-2022-00139
• Device Sequence Number: 4357716
• Product Code: JDL
• UDI-Device Identifier: M684260000271
• UDI-Public: M684260000271
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 26000027
• Device Catalogue Number: 26000027
• Device Lot Number: 1408406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown