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

Model Number	26000026
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, patient was revised due to dislocation/subluxation|infection|adverse soft tissue reaction to particulate debris.Srnjr number: 5116346.Side: r.Gender: m.Non revised products: product id: ppw39122 profemur® r ha coated prox body small v4/ lot.No: 127487759/ qty: 1.Product id: ppw38000 profemur® 135mm stem straight/taper size 10/ lot.No: u0266735/ qty: 1.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19614647
• Report Number: 3010536692-2024-00374
• Device Sequence Number: 17646746
• Product Code: JDL
• UDI-Device Identifier: M684260000261
• UDI-Public: M684260000261
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 10/17/2024

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: 26000026
• Device Catalogue Number: 26000026
• Device Lot Number: 78660969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 10/17/2024
• 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: Male