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

Model Number	38AM5235
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, left cup revision.Additional information on 05/31/2022: the 52mm metal head was converted to a zimmerbiomet 52mm dual mobility.We preserved the stem, neck and cup.Dr.Russo also utilized our +3.5mm ceramic head.Metal was removed due to high metal ions in the patients blood test.
Additional Manufacturer Narrative
See investigation attach.
Additional Manufacturer Narrative
Section b.5 :additional information in description.
Event or Problem Description
Allegedly, initial report stated a left cup revision.However, additional information received on 05/31/2022 stated that the 52mm metal head was converted to a zimmer biomet 52mm dual mobility.The stem, neck and cup were preserved(not revised).Dr.(b)(6) also utilized our +3.5mm ceramic head.Metal head was removed due to high metal ions in the patients blood test.

• Brand Name: CONSERVE® TOTAL A-CLASS® HEAD
• 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: 14621165
• Report Number: 3010536692-2022-00211
• Device Sequence Number: 12015270
• Product Code: JDL
• UDI-Device Identifier: M68438AM52351
• UDI-Public: M68438AM52351
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 38AM5235
• Device Catalogue Number: 38AM5235
• Device Lot Number: 107482921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 06/07/2022
• 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