MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 38MM FEMORAL HEAD; HIP COMPONENT

Model Number	38AC3800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 unknown reasons.Components not revised: dynasty® a-class® 38mm 15dg group e crosslinked poly liner product id: dlxple38 lot: 0501142452.Dynasty® bf shell 54mm group e product id: dsbfge54 lot: 1201210358.Profemur® z femoral stem s 2 1/3 tp coated cement less product id: pha00262 lot: 0901201577.Cancellous self-tapping 6.5mm bone screw 2.5cm length product id: 18080302 lot: 0111294020.

• Brand Name: CONSERVE TOTAL A-CLASS 38MM FEMORAL HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11727398
• Report Number: 3010536692-2021-00236
• Device Sequence Number: 16928481
• Product Code: JDL
• UDI-Device Identifier: M68438AC38001
• UDI-Public: M68438AC38001
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 38AC3800
• Device Catalogue Number: 38AC3800
• Device Lot Number: 090120899810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention