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

Model Number 38AM5235

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Metal Related Pathology (4530)

Event Type  Injury  

Event 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.

Manufacturer Narrative

See investigation attach.

Manufacturer Narrative

Section b.5 :additional information in description.

Event 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
• Type of Device: 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
• MDR Text Key: 294830455
• Report Number: 3010536692-2022-00211
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68438AM52351
• UDI-Public: M68438AM52351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention