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

Model Number	26000018
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, revision was performed for a case of prolapse.The bipolar cup side was damaged before revision, causing the patient's prolapse.Doctor's finding: the bipolar cup side was damaged (ring deformation) before the revision, which may have caused the patient's prolapse.Reporting party's findings and response: the ring in the outer cup was deformed and seemed to be loose, so the cup and head were replaced.Japan - (b)(4).

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER MEDIUM
• 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: 14800107
• Report Number: 3010536692-2022-00232
• Device Sequence Number: 5778964
• Product Code: JDL
• UDI-Device Identifier: M684260000181
• UDI-Public: M684260000181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 06/24/2022

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: 26000018
• Device Catalogue Number: 26000018
• Device Lot Number: 1615574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/24/2022
• 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