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

Model Number	26000020
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent index surgery on (b)(6) 2015.However, patient had pain and recurrent instability and underwent revision surgery on (b)(6) 2017.The cup, screws, liner, head and neck were revised.The stem pha00606, stem revision "profemur® z", lot: 068501170 was not revised.This revision surgery has been captured under microport incident group (b)(4).During revision surgery, patient was implanted with a phac1252 profemur® neck var/val 8dg short cobalt chrome and a 26000020 cocr transcend® femoral head 28mm slt taper x-long from wright medical.Patient received also a liner, insert and acetabular shell from stryker medical.Since her revision on (b)(6) 2017, patient has been complaining of issues but has not yet indicated what those issues are.Patient was told she needed another revision however it has not been indicated if it has happened yet.Chromium level is current 0.2.
Additional Manufacturer Narrative
See investigation attached.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER X-LONG
• 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: 14490294
• Report Number: 3010536692-2022-00203
• Device Sequence Number: 5335847
• Product Code: JDL
• UDI-Device Identifier: M684260000201
• UDI-Public: M684260000201
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2022

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: Other
• Device Model Number: 26000020
• Device Catalogue Number: 26000020
• Device Lot Number: 1405523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/03/2022; 05/03/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/03/2022; 07/20/2022
• 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 Age: 84 YR
• Patient Sex: Female