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

Model Number	26000017
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/17/2011
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, the patient had a revision surgery 2 days before.The patient is complaining of clicking of the right hip.It was felt she may have some metal impinging in the hip and it was felt she would benefit from revision in order to decrease the clicking, decrease risk of dislocation and increase the longevity of the prosthesis.Operative findings: when the hip was extended and externally rotated, the metal body of the profernur r did strike the posterior rim of the shell.It made a clicking noise but did not dislocate the ball because of large distance.Decreased offset with metal body impinging on the metal shell.Non revised products: product id: sphs8000 profemur® r 135mm.Stem size 10 mts.Finish straight/taper/ lot no.: 07493194/ qty: 1.Non mpo products: stryker mdm 58-mrn, 58 / 46 metal liner, 46-mrn poly ball, 30-mrn acetabular screws & 35-mrn acetabular screws.

• Brand Name: COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER SHORT
• 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: 17043482
• Report Number: 3010536692-2023-00105
• Device Sequence Number: 8784138
• Product Code: JDL
• UDI-Device Identifier: M684260000171
• UDI-Public: M684260000171
• 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: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 26000017
• Device Catalogue Number: 26000017
• Device Lot Number: 1392035
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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: 60 YR
• Patient Sex: Female