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

Model Number	26000025
Medical Device Problem Codes	Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	08/13/2021
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, on (b)(6) on 2021, patient presented to (b)(6) with complaints of right hip pain, weakness, and squeaking.An x-ray revealed marked superior migration of the femoral head in the acetabulum, some contact between the ball and the titanium shell, cup quite vertical and suspected loosening, the cup migrated more vertical with risk of the femoral head escaping, and with probable metal-on-metal in the revision surgery performed on patient on (b)(6) on 2021, his operating surgeon found failure of the right total hip prothesis with wear of the liner, dissociation and metallosis from metal-on-metal contact with the femoral head and acetabular component with abductor necrosis.In the revision surgery, the wright medical dynasty shell, liner, gladiator stem, and femoral head, were each removed and replaced with devices not manufactured by wright medical.
Additional Manufacturer Narrative
Due to human error this incident is a duplicate of manufacturer incident report number: (b)(4).Please void this report.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER SHORT
• 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: 13114326
• Report Number: 3010536692-2021-00611
• Device Sequence Number: 16993155
• Product Code: JDL
• UDI-Device Identifier: M684260000251
• UDI-Public: M684260000251
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K004043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• 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): 02/22/2022

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: 26000025
• Device Catalogue Number: 26000025
• Device Lot Number: 1609303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/22/2022
• 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